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This study is a randomized, open-label, double-cohort, national multi-center clinical research. The aim is to evaluate the newly diagnosed FIGO 2014 stage III-IV pathology of neoadjuvant therapy with fluzoparib combined with famitinib or fluzoparib combined with SHR-1701, based on the Fagotti laparoscopy score or upper abdominal Suidan's by the researchers The CT score assesses the efficacy and safety of patients with germline BRCA wild-type ovarian cancer who cannot achieve R0 resection or cannot tolerate initial cytoreductive surgery, as well as the efficacy and safety of surgery, adjuvant therapy, and combined maintenance treatment regimens based on fluzoparib.
The primary endpoint was the objective response rate (ORR) after neoadjuvant therapy as assessed by the researchers based on the RECIST v1.1 criteria. Meanwhile, the chemotherapy response score (CRS), event-free survival (EFS), disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) were also examined. The safety, tolerability and patient-reported outcomes (EQ-5D-5L) of the two cohorts were investigated.
A total of 104 newly diagnosed epithelial ovarian cancer patients with germline BRCA wild-type (FIGO 2014 stage III-IV) are planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuzuloparib and Famitinib | Experimental | fuzuloparib and famitinib |
|
| Fuzuloparib and SHR-1701 | Experimental | fuzuloparib and SHR-1701 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fuzuloparib | Drug | fuzuloparib 150mg bid PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate,ORR | From enrollment to the end of neoadjuvant treatment at around 8 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| event free survival | It is defined as the time from the start of randomization to the first occurrence of any of the following events (disease progression beyond surgical treatment, local or distant recurrence, death of any cause), whichever occurs first, up to 5 years. | |
| disease free survival |
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Inclusion criteria:
The criteria for judging that <s:1> cannot reach R0 resection include:
The criteria for the inability to tolerate surgery may be considered:
Body Mass Index: BMI≥40;
Multiple chronic diseases;
Malnutrition or hypoproteinemia;
Moderate to massive ascites;
Newly diagnosed venous thromboembolism;
Physical condition: ECOG PS > 2;
Other reasons as determined by the researcher;
<s:1> Absolute neutrophil count ≥1.5×109/L; <s:1> platelet count ≥100×109/L; <s:1> hemoglobin ≥9 g/dL; Serum albumin ≥3g/dL; Bilirubin ≤1.5 times ULN; <s:1> ALT and AST ≤2.5 times ULN, and ≤5 times ULN in the presence of liver metastasis; Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (calculated according to the Cockcroft-Gault formula);
Exclusion criteria:
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| Famitinib | Drug | famitinib 10mg qd PO |
|
| SHR-1701 | Drug | SHR-1701 1800 mg IV Q3W |
|
| It is defined as the period from the first study medication in the adjuvant therapy stage after cytoreductive surgery to disease recurrence or death due to any cause (whichever occurs first), up to 5 years. |
| progression free survival | It is defined as the period from the start of the first study medication in the maintenance treatment stage to tumor progression or death for any reason (whichever occurs first), up to 5 years. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| C584390 | famitinib |
| C000723862 | SHR-1701 |
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