NCT06490107

Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC

A Single-arm, Single-center Study of Durvalumab Combined With S-1 as Adjuvant Therapy for Resectable Biliary Tract Cancer(BTC) With High Risk of Recurrence

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence

Detailed description

Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to choose appropriate and effective adjuvant treatment. This study is a single center, single arm, prospective, phase II clinical study. This study plans to include 40 BTC patients after radical resection. The patients are evaluated by a multidisciplinary team (MDT) as high risk of recurrence. Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery. These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1, with a 21-day dosing cycle. After 8 cycles of adjuvant therapy, if the patients do not experience disease recurrence or intolerance，then the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage. The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle. If the patients experience recurrence, the subsequent treatment plan will be determined by the researchers based on treatment guidelines.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab combined with S-1	The treatment regimen for this study is as follows: First 8 cycles of adjuvant therapy: Durvalumab 1500mg, (Day 1, IV, Q3W) and S-1 40mg/m2 (Day1-14, BID, Q3W), up to 8 cycles. Maintenance therapy stage(6 cycles)：If the patients do not experience disease recurrence or intolerance after first 8 cycles of adjuvant therapy, then, Durvalumab 1500mg, (IV, Q4W), up to 6 cycles

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: China