Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

TPC induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)

GP induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)

TPC induction chemotherapy regimen contains Polymeric micellar paclitaxel, which is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel, cisplatin and capecitabine. TPC induction chemotherapy regimen (polymeric micellar paclitaxel 200 mg/m2 D1, cisplatin 75 mg/m2 D1, capecitabine 1000 mg/m2/day D1-14, every 3 weeks for 3 cycles).

TPC induction chemotherapy

GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1, every 3 weeks for 3 cycles)

GP induction chemotherapy

Hai-Qiang Mai

Hai-Qiang Mai, MD,PhD

Weijun Zhang

Shoumin Bai

Jiancong Sun

Zhigang Liu

Ning Zhang

Yajie Liu, MD

Kunyu Yang

The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.

TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial

Defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

Defined as the time from random assignment to death from any cause.

Defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).

Defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).

Tumour response was classified according to RECIST, version 1.1

Incidence of acute toxicity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. Acute adverse events, occurring during study treatment, and radiation-related late adverse events, occurring from 3 months after completion of radiotherapy, and chemotherapy-induced late adverse events, occurring from 3 months after completion of chemotherapy until end of follow up).

Sun Yat-sen University

Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Cyclophosphamide

capecitabine and cyclophosphamide as maintenance therapy every 3 weeks

Any physician's choice as maintenance therapy (except for XC regimen).

Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days

Any physician's choice as maintenance therapy (except for XC regimen)

Wenjin Yin, M.D.

Wenjin Yin

To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.

Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer

Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial

PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.

Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.

Deputy Chief of Breast Surgery Department

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Subjects randomly assigned to OGPT need to provide sufficient tissue for organoid culture. After successful organoid culture, drug screening will be performed, and they will be treated with drugs predicted to be sensitive by PDO drug susceptibility screening.

Subjects in the TPC arm will receive treatment with one of the following regimens selected by the physician following NCCN guidelines: capecitabine, gemcitabine, vinorelbine, and eribulin. If it is HER2-positive, anti-HER2 therapy can be combined with it, except for ADC drugs.

After the organoid culture is successful, the personalized drug library customized by our team will be used for screening. Sensitive drugs are selected based on the results of drug screening, and the most appropriate personalized treatment plan is selected based on NCCN guideline recommendations, drug safety, and conventional drugs used in the treatment of breast cancer. The personalized drug library customized by our team contains 55 drugs approved by the FDA. For specific usage, dosage and time intervals, please refer to the instructions of the corresponding drug.

Organoid-guided personalized treatment

25mg/m2, IV or 60mg/m² (oral), days 1 and 8, q3w

Eribulin

Yanxia Shi

This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.

This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer. Molecular subtype, presence of visceral metastases, and number of prior chemotherapy treatments for advanced or metastatic disease will stratify randomization. subjects in the OGPT arm will receive the treatment predicted to be the most effective by PDO drug sensitivity screening, and subjects in the TPC arm will receive treatment of physician's choice. The primary population to be included in the study will be patients with refractory breast cancer who have received multiple lines of prior therapy and who have at least one measurable target lesion according to RECIST 1.1 criteria.

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Patients With Relapsed and Refractory Breast Cancer：a Multicenter, Randomized, Controlled Phase III Trial

Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.

The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.

Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.

Disease Control Rate (DCR) was defined as the percentage of patients who have achieved complete response, partial response and stable disease

Incidence of Treatment-related Adverse Events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Principal Investigator, Professor

Kennedy Disease

Reproductive Control Agents

Androgens

Carboplatin

Mifepristone

Contraceptive Agents

Contraceptives, Oral

Contraceptive Agents, Female

Contraceptives, Postcoital

Hormones

Hormone Antagonists

Contraceptive Agents, Hormonal

Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle

Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle

The treating physician must select from one of the following regimens.

* Eribulin 1.4 mg/m2 IV Day 1 and Day 8 in a 21-day cycle
* Capecitabine 1000-1250 mg/m2 twice daily, orally Day 1-14 in a 21-day cycle
* Paclitaxel 80 mg/m2 IV Day 1, Day 8 in a 21-day cycle
* Carboplatin AUC 6 IV Day 1 in a 21-day cycle
* Carboplatin AUC 2 IV Day 1, Day 8 and Day 15 in a 21-day cycle

Patients randomized to TPC may be offered crossover to enzalutamide plus mifepristone treatment at the time of disease progression if they continue to meet eligibility criteria.

Enzalutamide

The treating physician must select from one of the following regimens:

* Eribulin 1.4 mg/m2 IV Day 1 and Day 8 in a 21-day cycle
* Capecitabine 1000-1250 mg/m2 twice daily, orally Day 1-14 in a 21-day cycle
* Paclitaxel 80 mg/m2 IV Day 1, Day 8 in a 21-day cycle
* Carboplatin AUC 6 IV Day 1 in a 21-day cycle
* Carboplatin AUC 2 IV Day 1, Day 8 and Day 15 in a 21-day cycle

Tiffany Traina, MD

Ayca Gucalp, MD

Katia Khoury, MD

Hope Rugo, MD

Rita Nanda, MD

Erica Mayer, MD, MPH

Lisa Carey, MD

The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.

A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Committee (version 1.1).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma	NCT06301165	Nasopharyngeal ...	TPC induction c... GP induction ch...	18 Years - 65 Years	Sun Yat-sen University
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer	NCT05876065	Advanced Breast...	XC TPC	18 Years -	RenJi Hospital
Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer	NCT06268652	Breast Cancer Refractory Brea...	Organoid-guided... Gemcitabine Capecitabine Vinorelbine Eribulin	18 Years -	Sun Yat-sen University
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer	NCT06099769	Metastatic Brea...	Enzalutamide Mifepristone TPC	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for tpc

Every month we try and update this database with for tpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tpc

Every month we try and update this database with for tpc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.