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

NCT06611345 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-10-30
Completion
2027-03-30

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611345 on ClinicalTrials.gov