Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05935579
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Tract Neoplasms
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg will be administered intravenously once every three weeks, with intravenous infusion on Day 1 of each cycle.
  • Lenvatinib Oral Product — DRUG
    The dose of lenvatinib is 12mg/day for patients with a body weight of ≥60 kg, and 8mg/day for patients with a body weight of \<60 kg, taken once daily.
  • Chemotherapy — DRUG
    GEMOX regimen: Gemcitabine 1000mg/m2 will be administered intravenously over 30 minutes on Day 1 and Day 8; Oxaliplatin 100mg/m2 will be administered intravenously over 2 hours on Day 1, and the cycle will be repeated every 3 weeks.

Study Details

Explore the impact of the first-line application of Durvalumab combined with Lenvatinib, with or without chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers.

Key Dates

Start date
Dec 14, 2022
Status verified
Nov 2023
Primary completion
Dec 30, 2023
Completion
Dec 30, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and Lenvatinib
  • Active Comparator: Durvalumab and Lenvatinib plus chemotherapy

Primary Outcome Measure

Objective response rate [ Time Frame: Baseline up to approximately 6 months ]

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