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H101 and HAIC in Intrahepatic Mass-forming Cholangiocarcinoma
NCT05124002Phase 4
Key facts
- Status
- Recruiting
- Start
- Aug 2022
- Primary completion
- Apr 2026
- Countries
- 1
- Sponsor
- Beijing Tsinghua Changgung Hospital
- Drugs
- Oncorine
- Conditions
- cholangiocarcinoma (CCA)
01
Overview
Phase 4, open-label, single-arm trial of Oncorine in cholangiocarcinoma (CCA), sponsored by Beijing Tsinghua Changgung Hospital. Primary endpoint: Progression-Free Survival at 1 month. Started Aug 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
H101+HAIC
Recombinant Human Adenovirus Type 5 combined with HAIC of FOLFOX
03
Who it enrols
Adults with histologically confirmed unresectable intrahepatic mass-forming cholangiocarcinoma, measurable disease, and adequate organ function.
04
Endpoints
Primary
Progression-Free Survival
Secondary
1-year survival rate
Objective Response Rate
Disease Control Rate
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