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.

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

QL1706 in combination with bevacizumab and chemotherapy

Sintilimab in combination with bevacizumab

7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

QL1706

15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle

1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

200 mg administered as IV infusion on Day 1 of each 21-day cycle

Sintilimab

Jian Gao

Shukui Qin

Jia Fan

The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.

A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

OS was defined as the time from randomization to death due to any cause.

ORR was assessed by investigators per RECIST 1.1

DCR was assessed by investigators per RECIST 1.1

DOR was assessed by investigators per RECIST 1.1

PFS was assessed by investigators per RECIST 1.1

TTP was assessed by investigators per RECIST 1.1

ORR was assessed by investigators per mRECIST

DCR was assessed by investigators per mRECIST

DOR was assessed by investigators per mRECIST

PFS was assessed by investigators per mRECIST

TTP was assessed by investigators per mRECIST

Qilu Pharmaceutical Co., Ltd.

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle

Jin Li, MD

Jin Li

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.

QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

DCR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

DOR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

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.
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma	NCT05976568	Hepatocellular ...	QL1706 Bevacizumab Oxaliplatin inj... Capecitabine Sintilimab	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC	NCT05799820	Colorectal Carc...	QL1706 Bevacizumab Oxaliplatin inj... Capecitabine	18 Years - 80 Years	Qilu Pharmaceutical Co., Ltd.
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma	NCT05976568	Hepatocellular ...	QL1706 Bevacizumab Oxaliplatin inj... Capecitabine Sintilimab	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for oxaliplatin injection