Spots Global Cancer Trial Database for Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
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Trial Identification
Brief Title: Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
Official Title: Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer
Study ID: NCT06178445
Interventions
Study Description
Brief Summary: 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charité Universitätsmedizin, Berlin, , Germany
Krankenhaus Nordwest (KHNW), Frankfurt, , Germany
Hämatologisch-Onkologische Praxis Eppendorf (HOPE), Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Contact Details
Name: Salah-Eddin Al-Batran, Prof. Dr.
Affiliation: Frankfurter Institut fuer Klinische Krebsforschung IKF GmbH
Role: STUDY_CHAIR
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