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Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer

Study acronym: TRAP-BTC
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 8
    • Primary completion date: Jul 2026 to Dec 2026
    • Study completion date: Apr 2028 to Jul 2027
    v4
  2. Study sites: 4 to 7
    • Eligibility criteria expanded, about 49 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Jan 2024 to Apr 17, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients. Patients suffering from previously untreated HER2 (human epidermal growth factor receptor 2) positive, unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab, trastuzumab and gemcitabine/cisplatin (GemCis).
Trial Details
NCT Number NCT06178445
Lead Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel, MSD Sharp & Dohme GmbH, Germany
Conditions
(from sponsor)		 Biliary Tract Cancer, HER2 Gene Mutation, HER2
Related terms Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov