Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Oxaliplatin

Antimetabolites

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.

TQB2450 Injection

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

Anlotinib hydrochloride

Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;

Oxaliplatin injection

Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;

Capecitabine tablets

Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Gemcitabine hydrochloride injection

Yueyin Pan, Doctor

Guangyu An, Doctor

Aiping Zhou, Doctor

Lei Chen, Doctor

Dondong Lin, Doctor

Lin Shen, Doctor

Jiahong Dong, Doctor

Xiaoyan Lin, Doctor

Aimin Zang, master

Jinghua Gao, bachelor

Qingshan Li, bachelor

Yanqiao Zhang, Doctor

Xiaobing Chen, Doctor

Hong Qiu, Doctor

Chuang Peng, Doctor

Haijiao Yan, Doctor

Wei Li, Doctor

This study is a randomized, parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus chemotherapy as second-line treatment in subjects with advanced biliary cancer.

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer

A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Percentage of participants achieving complete response (CR) and partial response (PR).

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

The time when the participants first achieved complete or partial remission to disease progression.

Percentage of participants whose PFS has achieved at least 6 months.

Percentage of participants whose OS has achieved at least 6 months.

Percentage of participants whose OS has achieved at least 12 months.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Antibodies, Monoclonal

Doxorubicin

Liposomal doxorubicin

Immunoglobulins

Tyrosine Kinase Inhibitors

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer	NCT04809142	Advanced Biliar...	TQB2450 Injecti... Anlotinib hydro... Oxaliplatin inj... Capecitabine ta... Gemcitabine hyd...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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.
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.

Spots Global Cancer Trial Database for gemcitabine hydrochloride injection