NCT05350943

HAIC Combined With Toripalimab and Donafenib for Advanced BTC

Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Lu Wang, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.

Conditions

• Biliary Tract Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	HAIC	After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs.
DRUG	Gemcitabine	1000 mg/m\^2 in 100ml saline solution IV, d1, Q3W
DRUG	Oxaliplatin	85 mg/m\^2 in 500ml 5% glucose solution over 2 hours IV, d1, Q3W
DRUG	Toripalimab	3mg/kg (body weight \< 60kg) or 240 mg（body weight\>= 60kg）in 250 saline soluation, IV, Q3W
DRUG	Donafenib	0.2mg. P.O, BID, continuously

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-11-01
• Completion: 2023-11-01
• First posted: 2022-04-28
• Last updated: 2022-10-18

Locations

1 site across 1 country: China