Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Tislelizumab

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab

Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)

administered via Intravenous (IV) injection

Carboplatin injection

Cisplatin injection

Etoposide injection

Liang Shi, MD

This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study

The researchers will consider whether IPD is available to other researchers only after the paper is published

pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.

EFS is defined as the time from enrollment until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.

OS is defined as the time from enrollment until death from any cause.

The proportion of patients who have had a complete response or partial response (according to RECIST1.1) in all patients who have completed the neoadjuvant therapy.

Only patients with measurable lesions at baseline will be analyzed.

The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.

Beijing Chest Hospital, Capital Medical University

MD，Associate Chief Physician

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Sarcoma

Endometrial Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

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

Soft Tissue Sarcoma

Uterine Sarcoma

Anti-Infective Agents

Amino Acids

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Antibodies

Antibodies, Monoclonal

Doxorubicin

Liposomal doxorubicin

Immunoglobulins

Tyrosine Kinase Inhibitors

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tyrosine

First-line treatment: TQB2450 injection 1200mg,d1/Q3W+Carboplatin Injection, AUC=5 mg/ml.min,d1/Q3W + Paclitaxel Injection 175mg/m2,d1/Q3W;6-8 cycles;

Maintenance treatment: TQB2450 injection, 1200mg，d1/Q3W

First-line treatment: TQB2450 Injection 1200mg, d1/Q3W + Anlotinib Hydrochloride Capsules 8mg/qd, d8-21/Q3W + Carboplatin Injection AUC=5 mg/ml.min, d1/Q3W + Paclitaxel Injection 175mg/m2, d1/Q3W ; 6-8 cycles; Maintenance treatment: TQB2450 injection+ Anlotinib Hydrochloride Capsules 8mg/qd, d8-21/Q3W

First-line treatment stage:

TQB2450 injection 1200mg, d1/Q3W + anlotinib hydrochloride capsules 8mg/qd, d8-21/Q3W+ chemotherapy（① Doxorubicin Hydrochloride Injection 60mg/㎡，d1/Q3W; or ② Gemcitabine Hydrochloride Injection 900mg/㎡, d1, d8/Q3W+ Docetaxel Injection 75mg/㎡, d8/Q3W）; 6-8 cycles;

Maintenance phase:

TQB2450 injection 1200mg, d1/Q3W+ Anlotinib hydrochloride capsules 10mg/qd, d8-21/Q3W

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents the binding of PD-L1 to PD-1 and B7.1 receptors on the surface of T cells, thereby reactivating T cells and enhancing the immune response.

TQB2450 injection

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Anlotinib Hydrochloride Capsule

Carboplatin which s similar to alkylating agent, is a second-generation platinum anti-tumor drug, which mainly causes cross-linking of DNA within and between chains, destroys DNA molecules, and disintegrates the helix.

Carboplatin Injection

Paclitaxel is a diterpene alkaloid with anticancer activity

Paclitaxel Injection

Doxorubicin hydrochloride is a cycle non-specific anticancer chemotherapy drug, which directly acts on DNA, changes the nature of DNA template, and inhibits DNA polymerase.

Doxorubicin Hydrochloride Injection

Gemcitabine is a cell cycle specific antimetabolic drug, which mainly acts on tumor cells at the DNA synthesis stage.

Gemcitabine Hydrochloride Injection

Docetaxel is an anti-tumor drug of paclitaxel, which plays an anti-tumor role by interfering with the microtubule network necessary for cell Mitosis and interphase cell function.

Docetaxel injection

Xiaojun Chen, Doctor

Ke Wang, Doctor

Dapeng Li

Ruifang An

Hui Qiu, Doctor

Keqiang Zhang, Doctor

Hua Qian, Doctor

Yongjie Zhang, Doctor

Ying Yang, Doctor

Bingzhong Zhang, Doctor

Xiumin Li, Doctor

Chunyan Wang, Doctor

This study plans to enroll 69 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The experimental set is divided into lead-in trial and formal trial. The lead-in trial includes 9 subjects to observe the safety of the combination and determine the dosage of anlotinib dihydrochloride capsules before the formal phase.

The formal trial includes 60 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The purpose is to evaluate efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules for first-line treatment and maintenance treatment of patient with advanced endometrial cancer or sarcoma of uterus, and explore biomarkers related to efficacy, mechanism of action, safety and/or pathological mechanisms, the surgical conversion rate. ORR is the primary endpoint.

Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.

Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Controlled, Phase II Clinical Trial.

The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases with complete remission and partial remission

From randomization to the first occurrence of disease progression or death from any cause. Disease progression refers to tumor growth, or the metastasis of primary tumor lesions, or the discovery of new lesions, etc.

From randomization to the time of death of death from any cause

The period from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).

the proportion of patients whose tumors shrink or remain stable for a certain period of time, including complete remission (CR, Complete Response), partial remission (PR, Partial Response) and stable (SD, stable Disease) cases

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

The incidence of abnormal laboratory test indicators of participants by attachment 1 in the test protocol.

The proportion of subjects who meet the criteria and undergo radical resection surgery.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Carcinoma, Neuroendocrine

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

LBL-024+Etoposide+Cisplatin/Carboplatin Injection , dose A or dose B; Q3w

Initial dose - MTD; Q3W; intravenous infusion

LBL-024 for Injection

Etoposide Injection

Cisplatin for Injection

ling zang

xue kong

Xue Kong

lin shen

An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)

This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation phase and Phase II is a dose-expansion phase.

Phase Ib program to enroll patients with advanced neuroendocrine carcinoma (NEC) without systemic therapy.

To sequentially evaluate the safety and tolerability of LBL-024 in combination with etoposide and platinum (cisplatin or carboplatin) at different doses by the dose-escalation method.

Phase II program to enroll approximately 50 patients with advanced neuroendocrine carcinoma without systemic treatment.

This trial will enroll 68 patients in Phase Ib and Phase II study.

A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)

ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II .

DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib.

MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase Ib .

After taking a single dose, Time to reach maximum plasma concentration

The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects

The period from the participants first achieving CR or PR to disease progression.

Nanjing Leads Biolabs Co.,Ltd

Symptoms and General Pathology

Recurrence

Fluzoparib

Poly(ADP-ribose) Polymerase 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

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.

Carcinoma, Non-Small-Cell Lung

Micronutrients

Hematinics

Vitamins

Pemetrexed

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1).

Placebo given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1).

Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Anlotinib hydrochloride capsule

Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.

Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC	NCT06375109	Limited-stage S...	Tislelizumab Carboplatin inj... Cisplatin injec... Etoposide injec...	18 Years - 75 Years	Beijing Chest Hospital, Capital Medical University
Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.	NCT05481645	Advanced Endome... Sarcoma of Uter...	TQB2450 injecti... Anlotinib Hydro... Carboplatin Inj... Paclitaxel Inje... Doxorubicin Hyd... Gemcitabine Hyd... Docetaxel injec...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma	NCT06157827	Advanced Neuroe...	LBL-024 for Inj... Etoposide Injec... Cisplatin for I... Carboplatin Inj...	18 Years - 75 Years	Nanjing Leads Biolabs 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
Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.	NCT05481645	Advanced Endome... Sarcoma of Uter...	TQB2450 injecti... Anlotinib Hydro... Carboplatin Inj... Paclitaxel Inje... Doxorubicin Hyd... Gemcitabine Hyd... Docetaxel injec...	18 Years -	Chia Tai Tianqing Pharmaceutical Group 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
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer	NCT04439890	Advanced Non-sq...	Anlotinib hydro... Carboplatin inj... Pemetrexed diso... Placebo	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for carboplatin injection