Study of Distamab Vedotin and Carboplatin Combination for First-Line Treatment of Advanced HER2-Positive Ovarian Cancer

What this Trial Is About

Ovarian cancer is the deadliest among gynecological cancers. This trial explores a new treatment option for advanced ovarian cancer that expresses the HER2 protein. Researchers are studying the combination of Disitamab Vedotin RC48, a novel antibody-drug conjugate targeting HER2, with carboplatin chemotherapy. The study aims to evaluate the treatments safety and effectiveness in patients who have not previously received chemotherapy. Participants will receive RC48 at a dose of 2.5 mgkg on day 1 every three weeks, combined with carboplatin dosed at AUC 5-6 on day 1 every three weeks. Treatment continues for up to six cycles. This first-line treatment regimen is designed to provide an alternative with potentially fewer side effects than traditional chemotherapy alone. During the study, participants will be monitored for progression-free survival over about one year, with additional follow-ups up to five years to assess overall survival and adverse events. Evaluations include tumor response assessments and safety monitoring throughout the treatment period. The study provides careful observation of participant health and treatment effects over the course of the trial.

Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment