Fluzopari Combined With Apatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT05597527|
Recruitment Status : Not yet recruiting
First Posted : October 28, 2022
Last Update Posted : October 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Fluzopari and apatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Exploratory, Multicenter Clinical Study of Fluzopari Combined With Apatinib Neoadjuvant Therapy in Patients With Advanced Non R0 Resectable Ovarian Cancer|
|Estimated Study Start Date :||November 1, 2022|
|Estimated Primary Completion Date :||May 31, 2025|
|Estimated Study Completion Date :||May 31, 2025|
Experimental: Fluzopari and Apatinib group
Fluzopari and Apatinib were used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose should be strictly controlled according to the experimental design.
Drug: Fluzopari and apatinib
Fluzopari was used as 100mg capsules orally twice a day (one time in the morning and one time in the evening), every four weeks as a cycle, a total of 3-4 cycles. Apatinib was used as 250 mg orally once a day, every 4 weeks as a cycle, 2-3 cycles in total, and stop 4 weeks before operation.
- R0 resection rate [ Time Frame: 3-month ]The percentage of patients received R0 resection after Fluzopari and Apatinib neoadjuvant treatment.
- Overall Response Rate (ORR) [ Time Frame: 3-month ]ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.
- Disease Control Rate (DCR) [ Time Frame: 3-month ]Disease control rate is defined as the proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
- Complete pathologic response rate(CPR) [ Time Frame: 3-month ]Complete pathologic response rate is measured according to Miller-Panye system.
- Progression Free Survival (PFS) [ Time Frame: 3-year ]PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Overall survival (OS) [ Time Frame: 5 years ]OS is defined as the time from the study enrollment to death due to any cause.
- Incidence rate of adverse events [ Time Frame: 5 years ]The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05597527
|Contact: Lin An||13805015679||Linan640906@163.com|
|Fujian Cancer Hospital|
|Fuzhou, Fujian, China, 350014|
|Contact: Lin An 13805015679 Linan640906@163.com|
|Principal Investigator:||Lin An||Fujian Cancer Hospital|