NCT06611345

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancers (BTC)

Interventions

Type	Name	Description
DEVICE	Tumor Treating Fields	Tumor treating fields will be used each day.
DRUG	Durvalumab	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).
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.
DRUG	Cisplatin	Cisplatin 25 mg/m2 will be given on Days 1 and 8 of each cycle up to 8 cycles.

Timeline

• Start date: 2024-10-21
• Primary completion: 2026-10-30
• Completion: 2027-03-30
• First posted: 2024-09-24
• Last updated: 2024-10-26

Locations

1 site across 1 country: China