Study of Safety and Effectiveness of Combining Candenizumab, Lenvatinib, and SOX Treatment for HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma in Adults Aged 18 to 75 Years

What this Trial Is About

Researchers are evaluating the combination of candenizumab, lenvatinib, and the SOX regimen for treating patients with HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma that cannot be removed by surgery. The study focuses on patients who have not previously received systemic treatment for their advanced or metastatic disease, aiming to measure the objective response rate and observe survival outcomes and safety. The sponsor is Fujian Medical University. The study includes a phase 1 ramp-up test to adjust the dose of lenvatinib, followed by phase 2 treatment with six cycles of the combined drugs given every three weeks. Patients who do not experience disease progression enter phase 3, which involves maintenance therapy with candenizumab, lenvatinib, and tigio also every three weeks. This multi-stage treatment plan is designed to evaluate the combination therapys effects and safety over time. Participants will be monitored regularly with assessments of tumor response, survival times, and quality of life changes. Safety evaluations include tracking adverse events, dose adjustments, and treatment pauses. The study requires participants to have measurable lesions, normal organ function, and an estimated survival time longer than three months. The total study period extends through treatment and follow-up, allowing researchers to gather comprehensive data on treatment response and tolerability.

A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients