Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Gemcitabine

Rituximab

Cisplatin

Antineoplastic Agents, Immunological

Immunologic Factors

Antimetabolites

* Drug:Rituximab
* Drug:Cisplatin
* Drug:Gemcitabine

Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of 6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the patients were middle age and the impact for economy and society was incredible. For recurrent or metastatic HNSCC, the average life span was around 4-6 months. Most patients just can receive chemotherapy. However the chemotherapy can't have any survival benefit. Recently a study showed the Cetuximab plus chemotherapy with cisplatin and 5-fluorouracil had survival benefit in the recurrent or metastatic HNSCC. However in Taiwan, the cetuximab can't be given by health insurance for the patients of the situation.

A lot of investigations recently showed the B lymphocytes got involvements in the squamous cell carcinoma carcinogenesis and tumor progression. In addition the B cell will influence the tumor associated macrophages and myeloid derived suppressor cells. Those immune cells could decrease the affect of chemotherapy and radiotherapy. Thus the B cell depletion has the possibility to develop a new treatment policy. Therefore investigators create a pilot clinical trial using Rituximab plus chemotherapy with cisplatin and gemcitabine for recurrent or metastatic HNSCC.

Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients.

Unexpected adverse event. An AE that is not listed in the drug's current labeling, or An AE that is more severe or more specific than indicated in the labeling.

CT scan according to the RECIST 1.1 criteria.

The time from the study registration date to the first day of disease progression at any site or of death by any cause.

China Medical University Hospital

attending physician

Pharmaceutical Solutions

CP-751,871 will be administered as an open-label intravenous solution. Patients will remain under clinical observation for one hour post-infusion

CP-751,871

Jean-Pascal Machiels, MDPhD

This is an open-label phase II, multicenter study. Eligible patients will receive CP-751,871 in monotherapy (20 mg/kg IV infusion on Day 1 of 3-week cycles). Tumor check-up will be performed every 6-8 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator.

CP-751,871 will be administered as an open-label intravenous solution. All patients will be treated every 3 weeks until disease progression(by RECIST criteria) or unacceptable toxicity death or discontinuation from the study for any other reason.

Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after CP-751,871. Our study will allow translational research with biopsies at crucial timing:

(i) at baseline before any treatment, (ii) during the treatment with CP-751,871 (day 1, second cycle two hours after the injection of CP-751,871).

(iii) for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor resistance.

The baseline samples will allow an investigation of molecular profiles that reflect an inherent inter-patient variability and which will be predictive of response. Although the number of patients included is low, these data may contribute to understand the mechanisms of response and non-response to CP-751,871. Understanding the mechanisms of response to CP-751,871 will help in the rational design of further clinical trials in head and neck cancer using CP-751,871.

The on-treatment samples will help to dynamically monitor the molecular response to CP-751,871.

The study of involved pathways before and after administration of CP-751,871 could be performed using IHC, DNA sequence analysis and RNA expression profiling. Plasma samples could be also stored for further analysis.

A Study of CP-751,871 in Patients With Recurrent Squamous Head and Neck Carcinoma

A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Neoplasm Metastasis

Disease Attributes

Neoplastic Processes

Docetaxel

Cetuximab

Lenograstim

Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according

* Cetuximab 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
* Cetuximab dose will be 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
* Cetuximab dose will be 500mg/m2 IV every 2 weeks during the maintenance therapy.

Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles

Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles

G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.

cetuximab IV

No intervention, only biopsy for translational project.

Biopsies

Joel GUIGAY

PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.

OBJECTIVES:

Primary

* To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary
* To assess toxicities of TPEx combination
* Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival.
* Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.

OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.

Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.

Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.

Gustave Roussy, Cancer Campus, Grand Paris

Groupe Oncologie Radiotherapie Tete et Cou

Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.

* 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
* 500mg/m2 IV every 2 weeks during the maintenance therapy.

Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles

G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.

Biopsies: No intervention, only biopsy for translational project.

Age, Categorical

Age, Continuous

Sex: Female, Male

Belgium

France

Region of Enrollment

Pr. Joël GUIGAY

Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according

cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.

* 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
* 500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles

G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.

Biopsies: No intervention, only biopsy for translational project.

Objective Tumor Response Rate

Grade 1 to 5 Toxicity

2 patients not assessable for response at 12 weeks

Best Overall Response

Progression-free Survival

Overall Survival

Biomarkers

cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.

* 250 mg/m² over 60 minutes weekly on subsequent administrations
* 500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles
* Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks.

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Fluzoparib

Tubulin Modulators

Antimitotic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

The treatment period mainly includes:

1. Injection of Paclitaxel (Albumin-bound) at a dose of 260mg/m\^2 administered intravenously every 3 weeks as one treatment cycle, for 6 cycles.
2. Injection of Carboplatin (AUC=5) administered intravenously every 3 weeks as one treatment cycle, for 6 cycles.
3. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle, for 6 cycles.
4. Radiation therapy: Not mandatory.

Maintainance therapy period mainly includes:

1. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.
2. Oral administration of Fluzoparib capsules at a dose of 150mg, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.

Treatment period mainly include:

1. Injection of Paclitaxel (Albumin-bound) at a dose of 260mg/m\^2 administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles.
2. Injection of Carboplatin (AUC=5) administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles.
3. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles.
4. Radiation therapy: Not mandatory. Whether to combine radiation therapy is determined by the principal investigator based on the patient's condition. Radiation therapy includes external beam radiation and brachytherapy.

Maintainance therapy period mainly includes:

a) Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.

During the maintenance phase of treatment. Oral administration of Fluzoparib capsules at a dose of 150mg（N=78 participants）, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.

During the maintenance phase of treatment. Camrelizumab, 200 mg administered intravenously every 3 weeks until disease progression, intolerable toxicity, death, or up to 2 years.

Camrelizumab

Paclitaxel (albumin-bound) for injection, 260 mg/m\^2 administered intravenously in 3-week cycles for 6 cycles.

paclitaxel (albumin bound)

AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator

Carboplatin injection

Non-essential, decision to combine is made by the principal investigator based on the patient's condition.

External irradiation

Shuangzheng Jia, Ph D

SHUANGZHENG JIA

GUANGWEN YUAN, MD

This study is an open-label Phase II randomized controlled trial designed to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer. The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance.

The treatment of recurrent or metastatic endometrial carcinoma (R/M-EC) has entered the era of molecular marker oriented precision therapy. Meanwhile, several large multicenter Phase III RCT studies have been conducted, such as NRG-GY018, RUBY, DUO-E and AtTEnd, and suggested that chemotherapy combined with immunotherapy could significantly improve the prognosis of R/M-EC. Unfortunately, the efficacy of ICBs in Asian R/M-EC population is not obvious, with small size.

On the other hand, up to 63% of patients with R/M-EC have TP-53 gene mutations (TP53mut). And the efficacy of chemotherapy combined with immunotherapy in thse patients is controversial. In the RUBY study, TC combined with Dostarlimab reduced the risk of death in patients with TP53mut-R/M-EC by 59 percent. However, in the DUO-E study, chemotherapy combined with Durvalumab failed to improve serous -EC in 154 patients (approximately 92% TP53mut). Therefore, how to optimize the strategy of chemotherapy combined with immunotherapy in TP53mut-R/M-EC is urgently needed.

Considering TP53mut-EC patients with tumor local T-lymph Cell infiltration and PD-L1 expression were significantly higher than those of TP-53 gene wild type (TP53wt) patients. It was also suggested that ICB and PARPi had a good synergistic effect. The DUO-E study revealed the combination of Durvalumab and Olaparib maintenance therapy significantly improves the prognosis of serous EC.

Therefore, as an investigator-initiated open-label Phase II randomized controlled study, the study will include 117 patients with TP53mut-R/M-EC, and randomly divided 2:1 into experimental group and control group to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer. The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance.

Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer

Efficacy and Safety of Camrelizumab Plus Albumin-bound Paclitaxel/Carboplatin Followed by Camrelizumab With or Without Fluzoparib Maintenance Therapy for TP-53 Mutated Recurrent or Metastatic Endometrial Cancer: A Phase II Trial

PFS in patients with different (Homologous Recombination Deficiency)HRD status and (Homologous Recombination Repair)HRR mutations

The time between randomization and tumor progression or death

The duration of remission or complete disappearance of the patient's disease after treatment

The time between randomization and death.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Professor, M.D.

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Radium Ra 223 dichloride

Phase I Starting Dose of Ra-223 Dichloride: 50 kBq/kg by vein over several minutes on Day 1 of each 4-week cycle.

Phase II Starting Dose of Ra-223 Dichloride: MTD from Phase I.

Up to 3 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 6 participants will be enrolled in Phase II.

Phase I Starting Dose of Ra-223 Dichloride: 50 kBq/kg by vein over several minutes on Day 1 of each 4-week cycle.

Phase II Starting Dose of Ra-223 Dichloride: MTD from Phase I.

Ra-223 Dichloride

Vivek Subbiah, MD

The goal of this clinical research study is to find the highest tolerable dose of radium-223 dichloride that can be given to patients with osteosarcoma.

Radium-223 chloride is designed to work like radiation therapy in cells that are actively making bone. It is designed to target new bone growth in and around bone cancer and may kill cancer cells.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 6 participants will be enrolled in Phase II.

If you are found to be eligible to take part in this study, you will be assigned to a dose level of radium-223 dichloride based on when you join this study. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of radium-223 dichloride is found.

If you are enrolled in the Phase II portion, you will receive radium-223 dichloride at the highest dose that was tolerated in the Phase I portion.

Study Drug Administration:

You will receive radium-223 chloride by vein over several minutes on Day 1 of each 4-week cycle.

You should drink plenty of fluids before each study drug dose.

You and your caregivers will receive spoken and written instructions about safety precautions after receiving this drug.

Study Visits:

At all study visits, you will be asked about any drugs you may be taking and if you have had any side effects from them.

On Day 1 of Cycle 2-6:

* You will have a physical exam, including measurement of your vital signs
* You will complete a brief questionnaire about any pain that you may be experiencing. This questionnaire should take about 5-10 minutes to complete.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* If you can become pregnant, you will have a urine or blood pregnancy test. If the doctor thinks it is needed, you will also have an ultrasound to check for pregnancy. To take part in this study, you cannot be pregnant.

Within 1-3 weeks after Cycle 3:

* You will have scans such as a bone scan and CT or MRI scan to check the status of the disease.
* Blood (about 1 tablespoon) will be drawn for routine tests.

You may have other routine tests done, including a pregnancy test, if the study doctor thinks it is needed.

Length of Study Drug Dosing:

You may continue taking the study drug for up to 6 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over once you have completed the end-of-dosing visit (and follow-up visits if applicable).

End-of-Dosing Visit:

About 30 days after your last study drug dose:

* You will be asked about any drugs you may be taking and if you have had any side effects from them.
* You will have a physical exam, including measurement of your vital signs.
* You will complete a brief questionnaire about any pain that you may be experiencing. This questionnaire should take about 5-10 minutes to complete.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have scans such as a bone scan and CT or MRI scan to check the status of the disease.

Follow-Up Visits:

If you are younger than 18 years old, your height and weight will be measured 1 time a year until you turn 21. These measurements may stop earlier if your height stays about the same for 2 years in a row.

Information about your health status and any side effects (especially related to your bones) will be collected and reported to the study staff every year.

This is an investigational study. Radium-223 dichloride is commercially available and FDA approved for the treatment of certain types of prostate cancer. It is currently being used for research purposes only.

Up to 20 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma

The goal of this initial study is to determine the safety of escalating doses of monthly Ra-223 dichloride in the number of osteosarcoma participants with osteoblastic bone-forming metastases until MTD or a dose 100 kBq/kg dose is reached (whichever is first).

Alkaline phosphatase reduction to quantitative imaging techniques (99mTc-MDP, 18FDG-PET-CT, 18FNa PET-CT scans) to determine objective response of osteosarcoma indicator lesions to 223-radium dichloride. \>30% increase in SUV peak indicates progression, if \>30% decrease in SUV peak indicates a response and other does not meet above criteria or mixed response using the NAFCIST and PERCIST criteria.

Bayer

M.D. Anderson Cancer Center

Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.

Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles.

Escalation 50 kBq/kg

Escalation 75 kBq/kg

Escalation 100 kBq/kg

Expansion 100 kBq/kg

Dose level: 50 kBq/kg, 75 kBq/kg and 100 kBq/kg. Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.

Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles.

Escalation

Dose level: 100 kBq/kg. Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.

Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles.

Expansion

Total

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Vivek Subbiah,Associate Professor, Invest. Cancer Therapeutics

Maximum Tolerated Dose (MTD) of Ra-223 Dichloride in Osteosarcoma

>30% increase in SUV peak

>30% decrease in SUV peak

Other/Mixed Response

Number of Participants With Objective Response of Osteosarcoma Indicator Lesions to 223-Radium Dichloride

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)

KL-A167 Injection

The study is to evaluate the efficacy of KL-A167 injection in subjects with recurrent/metastatic Nasopharyngeal Carcinoma, as measured by Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

KL167-Ⅱ-05-CTP (NCT03848286) is a single-arm, open-label, multicenter, phase II study of KL-A167 in pts with R/M NPC. Eligible pts were diagnosed with histopathologically confirmed R/M nonkeratinizing NPC and had received ≥ two lines of chemotherapy. Pts received 900 mg KL-A167 every 2 weeks until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was overall response rate (ORR) evaluated by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1.

KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma

A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and Immune-related Response Evaluation Criteria In Solid Tumors 1.1 (irRECIST 1.1)

PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive

From the date of the first dose of KL-A167 to the time the response criteria are first met

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

subject will receive KL-A167 1200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, 4-6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day,4-6 cycles

subject will receive placebo every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, 4-6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, 4-6 cycles

KL-A167 4-6 cycles for combined therapy.KL-A167 maintenance.

KL-A167

4-6 cycles for combined therapy.Placebo maintenance.

Placebo

The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

This study is a randomized, double-blind, placebo-controlled and multicenter study. It is expected that patients with recurrent or metastatic nasopharyngeal carcinoma who had not received systematic anti-tumor treatment before are enrolled, and the efficacy and safety of KL-A167 injection combined with cisplatin and gemcitabine are compared with placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma. Subjects who meet the enrollment requirements will be randomized to the trial group or the control group according to the ratio of 2:1. The stratification factors are: liver metastasis (with vs without) and ECOG score (0 vs 1)

multicenter, double-blind, randomized, controlled phase III trial

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial

PFS, defined as the active comparator arm frist dosing of KL-A167 injection to the first occurrence of disease progression as determined by the investigators according to RECIST v1.1 or death from any cause, whichever occurs first

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first

Progression-free survival (PFS) assessed by the investigators according to RECIST V 1.1

The percentage of patients with CR and PR assessed by the Independent Review Committee and investigators according to RECIST v 1.1

The proportion of patients who have achieved CR，PR and SD assessed by the Independent Review Committee and investigators according to RECIST v 1.1

From the date that response criteria are first met to the first occurrence of PD as determined by the Independent Review Committee and investigators according to RECIST v1.1 or death from any cause, whichever occurs first

OS, defined as the time from randomization to death or lose of follow, whichever occurs first

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma	NCT04361409	Head and Neck S...	Rituximab Cisplatin Gemcitabine	20 Years - 65 Years	China Medical University Hospital
A Study of CP-751,871 in Patients With Recurrent Squamous Head and Neck Carcinoma	NCT00872404	Head and Neck C...	CP-751,871	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer	NCT01289522	Squamous Cell H... Recurrent or Me...	cetuximab IV Biopsies	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer	NCT06413992	Endometrial Car... TP53 Mutation Recurrent or Me...	Fluzoparib Camrelizumab paclitaxel (alb... Carboplatin inj... Carboplatin External irradi...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma	NCT01833520	Sarcoma	Ra-223 Dichlori...	15 Years -	M.D. Anderson Cancer Center
KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma	NCT03848286	Nasopharyngeal ... Recurrent or Me...	KL-A167 Injecti...	18 Years -	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer	NCT06413992	Endometrial Car... TP53 Mutation Recurrent or Me...	Fluzoparib Camrelizumab paclitaxel (alb... Carboplatin inj... Carboplatin External irradi...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma	NCT03848286	Nasopharyngeal ... Recurrent or Me...	KL-A167 Injecti...	18 Years -	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma	NCT05294172	Nasopharyngeal ... Recurrent or Me...	KL-A167 Gemcitabine Cisplatin Placebo	18 Years - 75 Years	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer	NCT01289522	Squamous Cell H... Recurrent or Me...	cetuximab IV Biopsies	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou

Spots Global Cancer Trial Database for recurrent or metastatic