A Phase Ib/II Clinical Study of Camrelizumab and Apatinib Plus GP in the Treatment of Advanced Biliary Tract Cancer

Metastatic Biliary Tract Cancer Clinical Trial

Official title:
Camrelizumab Combined With Apatinib and Gemcitabine Plus Cisplatin as First-line Therapy for Patients With Inoperable/Metastatic Biliary Tract Cancer (BTC): An Open-label, Single-arm, Single-center, Phase Ib/II Clinical Study

Status Not yet recruiting

Clinical Trial Summary

The objective of this study is to investigate the safety and tolerability of camrelizumab combined with apatinib and chemotherapies (gemcitabine and cisplatin) in patients with advanced biliary tract cancer (BTC).

Clinical Trial Description

The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll participants with advanced unresectable biliary tract cancer that had not previously treated with systemic therapy. ;

Study Design

Related Conditions & MeSH terms

Biliary Tract Neoplasms
Locally Advanced Biliary Tract Cancer
Metastatic Biliary Tract Cancer

Clinical Trial Details

NCT number	NCT05742750
Study type	Interventional
Source	Sun Yat-sen University
Contact	Dongsheng Zhang, M.D., Ph.D.
Phone	86-02087343795
Email	zhangdsh@sysucc.org.cn
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	March 1, 2023
Completion date	December 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03524508` - Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer	Phase 2
Completed	`NCT02866383` - Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients	Phase 2
Terminated	`NCT01096745` - Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer	Phase 2
Recruiting	`NCT06282120` - Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer