Phase III Trial of Chiauranib with Weekly Paclitaxel for Women with Platinum-Resistant or Platinum-Refractory Recurrent Ovarian Cancer

What this Trial Is About

Researchers are evaluating the efficacy and safety of Chiauranib combined with weekly paclitaxel compared to placebo plus weekly paclitaxel in women with platinum-refractory or platinum-resistant recurrent ovarian cancer. This phase III, randomized, double-blind study focuses on patients whose cancer progressed during or shortly after platinum-based therapy, aiming to understand the treatments impact on disease progression and survival. Participants are randomly assigned to receive either Chiauranib oral tablets at 50mg once daily plus intravenous paclitaxel on days 1, 8, and 15 of a 21-day cycle, or placebo tablets plus the same paclitaxel regimen. The combined treatment lasts up to six cycles. Those with stable disease or response after six cycles continue on single-agent Chiauranib or placebo until disease progression. During the study, participants undergo assessments including measuring tumor lesions, blood tests, and monitoring for side effects. The main outcomes measured are progression-free survival for up to one year and overall survival for up to two years. Additional outcomes include response rates, quality of life, and drug pharmacokinetics. Safety is closely monitored throughout the trial, which is expected to complete by July 2025.

Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer