NGS as the First-line Treatment in Advanced Biliary Tract Cancer

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT04172402
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • TS-1 — DRUG
    Intervention is administered to patients in this Arm.
  • Gemcitabine — DRUG
    Intervention is administered to patients in this Arm.
  • Nivolumab — DRUG
    Intervention is administered to patients in this Arm.

Study Details

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

Key Dates

Start date
Dec 27, 2019
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NGS
    Eligible patients will receive Nivolumab 240mg on day 1, gemcitabine 800 mg/m2/day on day 1 and S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 10 in a 2-week cycle. * BSA \< 1.25 m2: 80 mg/day * 1.25 m2 ≤ BSA \< 1.5 m2: 100 mg/day * BSA ≥ 1.5 m2: 120 mg/day The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 1 year ]

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