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| Name | Class |
|---|---|
| Hutchison Medipharma Limited | INDUSTRY |
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The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
Patients will have tests and exams to see if they are eligible for the clinical trial.
First-line chemotherapy regimen:
Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles):
Surufatinib(repeat every 3 weeks, total of 5 cycles):
Maintenance Therapy Regimen:
HRD-positive Patients:
HRD-negative or HRD Status Unknown Patients:
Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-line and maintenance therapy regimen | Experimental | First-line chemotherapy regimen:
Maintenance Therapy Regimen:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | First-line chemotherapy regimen:
Maintenance Therapy Regimen:
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Age: 18-75 years old (≥18, ≤75)
Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:
Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.
ECOG performance status score: 0-2.
Postoperative administration time ≤12 weeks.
Expected survival of at least 3 months.
Major organ function within 7 days prior to treatment meets the following criteria:
Biochemical parameters must meet the following standards:
Women of childbearing potential must use effective contraception.
Subjects must voluntarily join the study and sign the informed consent form (ICF).
Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bairong Xia, Doctor | Contact | 18604516165 | xiabairong9999@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bairong Xia, Doctor | Anhui Provincial Cancer Hospital | Study Chair |
| Wenjing Jiang | Anhui Provincial Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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| Disease control rate | the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated | 3-month |
| Overall survival | the date of enrollment to the date of death from any cause | 3-years |
| Adverse event | Adverse medical events in clinical trial subjects treated with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib | 3-month |
| 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 |
|---|---|
| D017239 | Paclitaxel |
| C000717729 | surufatinib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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