A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
A Single-Arm, Phase 1b Study to Assess Tumor-Treating Fields (TTF) in Combination With Durvalumab and Gemcitabine/Cisplatin (GemCis) as the First-Line Treatment of Unresectable Biliary Tract Cancers (BTC)
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
60 participants
Oct 21, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Tumor treating fields will be used each day.
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 1000 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
Cisplatin 25 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
Locations(1)
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NCT06611345