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This is a single arm, multi center, exploratory clinical study to evaluate the efficacy and safety of fluzoparide combined with alpatinib as neoadjuvant therapy in patients with BRCA1/2 gene mutation or HRD gene mutation, advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzopari and Apatinib group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzopari and apatinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The percentage of patients received R0 resection after Fluzopari and Apatinib neoadjuvant treatment. | 3-month |
| Overall Response Rate (ORR) | 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. | 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | 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. | 3-month |
| Complete pathologic response rate(CPR) |
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Inclusion Criteria:
(1) Fagotti score ≥ 8; (2) When the laparoscopic evaluation method is difficult to implement, the upper abdomen CT score is ≥ 3 (SUDANCT score);
The criteria for surgical intolerance are as follows:
(3) Body mass index: BMI ≥ 40.0; (4) Various chronic diseases; (5) Malnutrition or hypoproteinemia; (6) Moderate to massive ascites; 6. ECOG PS 0-1 point; 7. The main organs function normally and meet the following standards:
The blood routine examination standard shall meet: (no blood transfusion within 14 days)
Biochemical examination shall meet the following standards:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin An | Contact | 13805015679 | Linan640906@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin An | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
Complete pathologic response rate is measured according to Miller-Panye system.
| 3-month |
| Progression Free Survival (PFS) | 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. | 3-year |
| Overall survival (OS) | OS is defined as the time from the study enrollment to death due to any cause. | 5 years |
| Incidence rate of adverse events | The ratio of the number of cases with adverse events to the total number of cases available for evaluation. | 5 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |