NCT04333927

Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer: a Phase II, Multicenter, Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

Detailed description

The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.

Conditions

• Biliary Tract Cancer
• Extrahepatic Cholangiocarcinoma
• Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).
OTHER	Observation	Patients in observation group will not receive any anti-cancer therapy.
PROCEDURE	Immunotherapy	Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.
RADIATION	Radiotherapy	45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2020-04-03
• Last updated: 2020-06-23

Locations

1 site across 1 country: China