Phase 1B2 Study of Trastuzumab, Bevacizumab, and Paclitaxel as Second-line Treatment for HER2-positive Advanced Gastric Cancer

What this Trial Is About

Researchers are evaluating a combination of trastuzumab, bevacizumab, and paclitaxel as a second-line treatment for patients with HER2-positive advanced gastric cancer who have progressed after first-line chemotherapy including trastuzumab or other anti-HER2 agents. This multicenter, open-label phase 2 study aims to assess the progression-free survival of this treatment combination in this patient group. The treatment involves administering trastuzumab at 4 mgkg every 2 weeks to maintain concentration after an initial loading dose in prior therapy. Bevacizumab is given at 5 mgkg every 2 weeks, a regimen used in metastatic colorectal cancer. Paclitaxel is delivered at 80 mgm2 weekly for three weeks followed by a one-week break, with dose adjustments made if side effects occur. Each treatment cycle lasts 4 weeks, and this is a single-arm study where all participants receive the combination treatment. Participants will undergo evaluations including imaging and laboratory tests to measure tumor response using RECIST 1.1 criteria and assess organ function. Researchers will monitor progression-free survival for up to 36 months. Eligibility includes patients aged 19 years or older with measurable lesions and adequate organ and cardiac function. Safety and treatment effects will be closely observed throughout the study period.

Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy