COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable inTrahepatic Cholangiocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Immunotherapy
- Intrahepatic Cholangiocarcinoma
- Radiotherapy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
The trial will recruit 184 patients, and they will be randomized (1:1) into two groups (radiotherapy+anti-PD-1 group, gemcitabine+cisplatin group). Patients in radiotherapy+anti-PD-1 group will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a t...
The trial will recruit 184 patients, and they will be randomized (1:1) into two groups (radiotherapy+anti-PD-1 group, gemcitabine+cisplatin group). Patients in radiotherapy+anti-PD-1 group will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 40Gy. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy. Patients in chemotherapy group will receive cisplatin 25mg/m2 intravenously (day 1 and day 8) and then gemcitabine 1000mg/m2 intravenously (day 1 and day 8) every 3 weeks (1 cycle), for 8 cycles.
Tracking Information
- NCT #
- NCT03898895
- Collaborators
- Not Provided
- Investigators
- Study Chair: Ming Kuang, PhD First Affiliated Hospital, Sun Yat-Sen University
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