Mullanpur Dakha

Researchers are evaluating the effectiveness and safety of adding trastuzumab to chemotherapy compared to chemotherapy alone as the first treatment for patients with HER2-positive advanced or metastatic biliary tract cancers. These cancers, which include gallbladder cancer and cholangiocarcinomas, are rare and aggressive with poor outcomes. The study is a Phase III randomized, open-label trial aiming to provide definitive evidence on whether HER2-targeted therapy benefits this patient group. Participants will be randomly assigned to one of two groups. One group (Arm A) will receive trastuzumab combined with chemotherapy, which may include gemcitabine and cisplatin, with or without nab-paclitaxel, administered in cycles every three weeks. The other group (Arm B) will receive chemotherapy alone using the same regimens. Treatment continues until the cancer worsens, unacceptable side effects occur, the patient withdraws consent, or death. Immunotherapy may also be used at the treating physician’s discretion. During the study, patients will be closely monitored with assessments to measure progression-free survival at six months as the main outcome. Secondary outcomes include overall survival, response rates, quality of life, and side effects. The trial plans to enroll 196 patients at a single center in India over five years, with an additional six months of follow-up after the last patient is enrolled. Participants are expected to undergo regular evaluations including scans and laboratory tests to track disease status and safety throughout the study.