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

NCT06490107 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-08

No results posted yet for this study

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

Conditions

  • Biliary Tract Cancer

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Yongkun Sun · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490107 on ClinicalTrials.gov