Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The majority of ovarian cancer patients with standardized treatment, including tumor cell reduction and postoperatively platinum-based combination chemotherapy, will still experience tumor recurrence and multiple recurrences within 6-18 months.With the increase in the number of recurrences, the intertherapeutic period will shorten and eventually drug resistance will emerge.The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.To evaluate the efficacy and safety of Paclitaxel (Albumin-Bound) combination with carboplatin in Chinese patients with platinum-sensitive recurrent ovarian cancer, this clinical study is planned.
This study is a multicenter, open, single arm, phase 2 clinical study in patients with platinum-sensitive recurrent ovarian cancer.75 patients were planned to be enrolled, and the eligible patients were given the following regimen: Paclitaxel (Albumin-Bound) 130 mg/m\^2, i.v., d1, d8;Carboplatin AUC 5, i.v.,d1;Every 21 days is a cycle, a total of 6 cycles.This study will be divided into three stages.The baseline period:Patients will complete screening tests at baseline to assess eligibility for inclusion criteria.Treatment period:(from the first dose to the last treatment cycle).Imaging tumor assessment was performed every 2 cycles (i.e. 6 weeks).Follow-up period:At the end of the study, patients were followed up by telephone or at the study center every 3 months to collect survival status and subsequent antitumor treatment until death or loss of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
The dose of intravenous chemotherapy drug is calculated according to the body surface area.When patients have serious adverse events, dose suspension and dose reduction are allowed. Paclitaxel (albumin-bound) was allowed to be reduced only twice (20% standard dose reduction in the first dose and 20% lower in the second dose).Once the dose is reduced, all subsequent doses should be maintained at reduced dosage.
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Progression-free survival(PFS)
From date of randomization until the date of first documented progression or died
Time frame: up to 36 months
Objective response rate(ORR)
The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR.
Time frame: up to 36 months
Overall survival(OS)
From date of randomization until the date of death from any cause
Time frame: up to 36 months
disease control rate(DCR)
including CR, PR, SD
Time frame: up to 36 months
hematological toxicity and non-hematological toxicity
including hematological toxicity and non-hematological toxicity
Time frame: up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.