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The goal of this type of clinical trial study is to evaluate the safety and efficacy of Pamiparib combined with Surufatinib as a new neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer.
Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive Pamiparib twice daily and Surufatinib once daily taken by mouth every 3 weeks.
Patients who had no progression after neoadjuvant therapy were treated with surgery, and 4 cycles of chemotherapy were given after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experience group | Experimental | Pamiparib 40 mg, BID, oral, 3 weeks as a cycle, 3 cycles Surufatinib 250 mg, QD, oral, 3 weeks as a cycle, 2 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamiparib | Drug | Pamiparib capsule 40 mg/time, twice a day, oral, 3 weeks as a cycle, 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | the percentage of patients received R0 resection after Pamiparib combined with Surufatinib neoadjuvant therapy | 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) After Neoadjuvant treatment | Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bai-Rong Xia, MD | Anhui Provincial Cancer Hospital | Study Chair |
| Wenjing Jiang | Anhui Provincial Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Hefei | Anhui | 230001 | 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 |
|---|---|
| C000707927 | pamiparib |
| C000717729 | surufatinib |
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| Surufatinib | Drug | Surufatinib 250 mg/time, once a day, oral, 3 weeks as a cycle, 2 cycles |
|
|
| 3-month |
| Pathological complete remission rate | No residual invasive carcinoma was found under the microscope, but ductal carcinoma in situ could be found; In addition, compare the amount of cancer cells in the specimen before and after the new adjuvant therapy, and use of the Miller Payne grading system to evaluate the effect of the new adjuvant therapy | 3-month |
| 12-month disease-free survival rate | The rate of patients who did not have any event from the beginning of enrollment to 12 months, including disease progression, inoperable, local or remote recurrence, and death from any cause | 12 months |
| 12-month survival rate | Rate of patients who did not have a death event from enrollment to 12 months | 12 months |
| 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 |