Study Comparing Trastuzumab Plus Chemotherapy Versus Chemotherapy Alone for First Treatment of HER2-Positive Advanced or Metastatic Biliary Tract Cancer A Randomized Phase III Clinical Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding trastuzumab to chemotherapy compared to chemotherapy alone as a first treatment in patients with HER2-positive advanced or metastatic biliary tract cancers. These cancers, including gallbladder cancer and cholangiocarcinomas, are rare and aggressive with limited treatment options and poor prognosis. This Phase III trial builds on earlier findings suggesting potential benefit from trastuzumab in this molecular subgroup. Participants will be randomly assigned to one of two groups. One group will receive trastuzumab combined with chemotherapy regimens including gemcitabine and cisplatin, with or without nab-paclitaxel. The other group will receive chemotherapy alone, using similar drugs but without trastuzumab. Treatments are given in cycles every three weeks and continue until the disease worsens, unacceptable side effects occur, consent is withdrawn, or death. Immunotherapy may also be given based on physician choice. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their cancer and overall health. Researchers will measure progression-free survival at six months as the main outcome, along with overall survival, response rates, quality of life, and safety throughout treatment cycles. The study plans to enroll 196 patients over five years with an additional six months of follow-up after the last patient is enrolled.

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