NCT04809142

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Biliary Cancer

Interventions

Type	Name	Description
DRUG	TQB2450 Injection	TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
DRUG	Anlotinib hydrochloride	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).
DRUG	Oxaliplatin injection	Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
DRUG	Capecitabine tablets	Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
DRUG	Gemcitabine hydrochloride injection	Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-03-18
• Completion: 2023-02-01
• First posted: 2021-03-22
• Last updated: 2021-03-22

Locations

17 sites across 1 country: China