Platinum-resistant Recurrent Ovarian Cancer Clinical Trial
Official title:
A Single-arm, Multicenter, Phase II Clinical Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer
This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer.
This study will be conducted in two stages (dose escalation trial and phase II trial). Dose escalation trial: To explore the safety and tolerability of Docetaxel for Injection (Albumin-bound) (75 mg/m^2 and 100 mg/m^2) combined with Bevacizumab 15 mg/kg. Dose escalation will be started at low dose and proceed in turn. Phase II trial: According to the recommended phase II dose (RP2D) determined in the dose escalation trial, a phase II study of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab will be conducted to observe the efficacy of the combination regimen, with overall response rate (ORR) as the primary study endpoint. Simon's optimal 2-stage design will be adopted for phase II study. ;
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