Fallopian Tube Cancer Clinical Trial
Official title:
Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.
The study objective is to investigate the efficacy and safety of p53 combined with
chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer,
Fallopian Tube Cancer, and Primary Peritoneal Cancer.
study design: open-labeled, active controlled, randomized, phase 2 treatments: experiment
group will consist of intraperitoneal p53 (2 x 10^12 viral particles) plus cisplatin 150
mg/m^2, and Paclitaxel 175 mg/m^2 IV over 3 h on day 1; every 21 d for 6 cycles.
study end points: response rate, progression-free survival, overall survival and Karnofsky
score（KPS).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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