NCT03898895

COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer

Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a single-arm, phase II trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody in unresectable biliary tract cancer patients.

Detailed description

The trial will recruit 36 patients, and they will undergo radiotherapy plus anti-PD-1 antibody. Patients will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 45Gy. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.

Conditions

• Biliary Tract Cancer
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Radiotherapy+anti-PD-1 antibody	The total radiation dose is over 45Gy without damaging organic fucntion. Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death or withdrawal. If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression. If progression is confirmed, the camrelizumab should be stopped.

Timeline

• Start date: 2019-12-10
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2019-04-02
• Last updated: 2022-06-02

Locations

1 site across 1 country: China