NCT07062263View on ClinicalTrials.gov

Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

July 21, 2023

Primary Completion Date

July 31, 2029

Study Completion Date

July 31, 2029

Conditions
Biliary Tract CancerHER2-positive CancerAdvanced CancerUnresectable Biliary Tract CarcinomaMetastatic Biliary Tract Carcinoma
Interventions
DRUG

Trastuzumab

Inj Trastuzumab given in a dose of 8mg/kg intravenously over 90 mins as first dose and subsequent doses at a dose of 6mg/kg intravenously over 30-60 minutes in 3 weekly cycle along with standard of care chemotherapy

DRUG

Chemotherapy

Gemcitabine + cisplatin OR Gemcitabine-cisplatin-Nab-Paclitaxel given as a standard of care, chemotherapy as per the institutional guidlines

Trial Locations (6)

110017

NOT_YET_RECRUITING

MAX Super Speciality Hospital, SAKET, Delhi

140901

RECRUITING

Homi Bhabha Cancer Hospital and Research Centre, Mūllānpur

221005

RECRUITING

Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH), Varanasi

400012

RECRUITING

Tata Memorial Hospital, Mumbai

751003

NOT_YET_RECRUITING

Institute of Medical Sciences & SUM Hospital, Bhubaneswar

842004

NOT_YET_RECRUITING

Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, Muzaffarpur

All Listed Sponsors
lead

Tata Memorial Centre

OTHER