Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer

Sponsor
Asan Medical Center
Study ID
NCT04308174
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Biliary Tract Neoplasms
  • Cholangiocarcinoma
  • Gallbladder Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab + Gem/Cis — DRUG
    Neoadjuvant Durvalumab + Gemcitabine/Cisplatin
  • Gem/Cis — DRUG
    Neoadjuvant Gemcitabine/Cisplatin

Study Details

Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.

Key Dates

Start date
May 20, 2020
Status verified
Jan 2025
Primary completion
Jun 30, 2023
Completion
Dec 30, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Gem/Cis
    \<Investigational arm: preoperative phase (up to 4 cycles)\> Durvalumab 1,500 mg IV on Day 1, every 3 weeks (preop period) 1,500 mg IV Day 1, every 4 weeks (postop period) Gemcitabine 1,000 mg IV on Day 1 and 8, every 3 weeks Cisplatin 25 mg IV on Day 1 and 8, every 3 weeks \<Postoperative therapy for all patients (up to 6 cycles)\> Durvalumab 1,500 mg IV Day 1, every 4 weeks (postop period)
  • Active Comparator: Gem/Cis
    \<Control arm: preoperative phase (up to 4 cycles)\> Gemcitabine 1,000 mg IV on Day 1 and 8, every 3 weeks Cisplatin 25 mg IV on Day 1 and 8, every 3 weeks \<Postoperative therapy for all patients (up to 6 cycles)\> Durvalumab 1,500 mg IV Day 1, every 4 weeks (postop period)

Primary Outcome Measure

Ro resection rate [ Time Frame: 4 months ]

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