A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers

Sponsor
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Study ID
NCT06611345
Status
Recruiting
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Conditions

  • Biliary Tract Cancers (BTC)

Eligibility Criteria

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

Interventions

  • Tumor Treating Fields — DEVICE
    Tumor treating fields will be used each day.
  • Durvalumab — DRUG
    Durvalumab 1500 mg will be administrated via Intravenous (IV) infusion Once Every 3 weeks (Q3W) on day 1 of each cycle for up to 8 cycles. And then 1500 mg Once Every 4 weeks (Q4W) on day 1 of each cycle until confirmed progressive disease (PD).
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
  • Cisplatin — DRUG
    Cisplatin 25 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.

Study Details

Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis. This study is to evaluate the efficacy and safety of adding TTF to the established regimen of durvalumab plus GemCis for the treatment of patients with previously untreated, unresectable BTC.

Key Dates

Start date
Oct 21, 2024
Status verified
Aug 2024
Primary completion
Oct 30, 2026
Completion
Mar 30, 2027

Study Design

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

Arms

  • Experimental: Tumor Treating Fields combined with durvalumab and GemCis

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 24 months after the enrollment of the last patient. ]

Central Contacts