NCT04809142

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

Status unknown Phase 3 Last updated 22 March 2021

What this trial tests

Phase 3 trial testing TQB2450 Injection in Advanced Biliary Cancer in 392 participants. Status unknown.

Timeline

4 February 2021

Primary endpoint
18 March 2022

1 February 2023

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	392
Start date	4 February 2021
Primary completion	18 March 2022
Estimated completion	1 February 2023
Sites	17 locations across China

Drugs / interventions tested

• TQB2450 Injection — full drug profile →
• Anlotinib hydrochloride
• Oxaliplatin injection — full drug profile →
• Capecitabine tablets — full drug profile →
• Gemcitabine hydrochloride injection — full drug profile →

Conditions studied

• Advanced Biliary Cancer — all drugs for Advanced Biliary Cancer →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced Biliary Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis.
   Zhou J, Sun Y, Zhang W, Yuan J, et al · · 2023 · cited 41× · PMID 35491432 · DOI 10.1002/hep.32548
2. Chemotherapy for Biliary Tract Cancer in 2021.
   Sasaki T, Takeda T, Okamoto T, Ozaka M, et al · · 2021 · cited 39× · PMID 34300274 · DOI 10.3390/jcm10143108
3. Efficacy and Safety of Anti-PD1/PDL1 in Advanced Biliary Tract Cancer: A Systematic Review and Meta-Analysis.
   Jiang Q, Huang J, Zhang B, Li X, et al · · 2022 · cited 5× · PMID 35309350 · DOI 10.3389/fimmu.2022.801909
4. Benmelstobart+anlotinib: an emerging therapeutic option in the targeted-immunotherapy era.
   Cheng P, Gu H, Chen Q, Zhao G, et al · · 2026 · PMID 42052493 · DOI 10.3389/fonc.2026.1748214
5. Application of immune checkpoint inhibitors in hepatobiliary cancers.
   Yuan J, Xu L, Zhou J, Shen L. · · 2022 · PMID 40636135 · DOI 10.1016/j.iliver.2022.03.002