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

Sponsor
Dai, Guanghai
Study ID
NCT06708858
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib — DRUG
    200mg，qd，po
  • Gemcitabine — DRUG
    1000mg/ m2, IV，d1，8，q3w
  • Cisplatin — DRUG
    25mg/m2，IV，d1，8，q3w
  • Durvalumab — DRUG
    1500mg，IV，d1，q3w
  • Pembrolizumab — DRUG
    200mg，IV，d1，q3w

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Jul 31, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GC+IO+Surufatinib
    Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab

Primary Outcome Measure

ORR [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks and then every 8 weeks, through study completion, an average of 1 year ]

Central Contacts

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