MedTrace Logo

Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer

NCT06708858 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-11-27

No results posted yet for this study

Summary

This phase II trial studies how well gemcitabine, cisplatin and durvalumab/Pembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.

Conditions

  • Advanced Biliary Tract Cancer

Interventions

DRUG

Surufatinib

200mg，qd，po

DRUG

Gemcitabine

1000mg/ m2, IV，d1，8，q3w

DRUG

Cisplatin

25mg/m2，IV，d1，8，q3w

DRUG

Durvalumab

1500mg，IV，d1，q3w

DRUG

Pembrolizumab

200mg，IV，d1，q3w

Sponsors & Collaborators

  • Dai, Guanghai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-12-31
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06708858 on ClinicalTrials.gov