Ovarian Cancer
Conditions
Interventions
experimental group:Pamiparib combined with Surufatinib
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Informed consent must be provided and recorded in the research center before any procedure of the experiment begins; 2. Female patients >=18 years old; 3. Biopsy obtained by open surgery, laparoscopic surgery or crude needle puncture was confirmed by local central laboratory pathology as high-grade serous or endometrioid ovarian cancer, peritoneal or fallopian tube cancer (hereinafter referred to as ovarian cancer), FIGO stage III-IV; 4. Blood and tissue samples of patients before, during, and after treatment can be obtained and subject agrees to submit blood and tissue samples to the central laboratory for extended research purposes of this test; 5. There is at least one lesion that can be measured by CT/MRI; 6. For patients judged by professional gynecological oncologists as unable to achieve R0 tumor reduction or unable to tolerate surgery, the criteria for failure to achieve R0 tumor reduction include but are not limited to: (1) Fagotti endoscopy score >=8 points; (2) When laparoscopic evaluation method is difficult to implement, upper abdominal CT score >=3 points can be used; (3) The criteria of intolerance to surgery can be considered: (4) Aged >=80 years; (5) Body mass index: BMI>=40.0; (6) Multiple chronic diseases; (7) Malnutrition or hypoproteinemia; (8) Moderate to massive ascites; (9) Newly diagnosed venous thromboembolism (except for intermuscular venous thrombosis) (survival greater than 12 weeks); (10) Physical state: ECOG >2; 7. Expected survival > 12 weeks; 8. The ECOG score of the patient was 0-2; 9. Good organ function, including: (1) Bone marrow function: neutrophil count >=1500/µL; Platelet >=100,000/µL; Hemoglobin >=9g/dL; (2) Liver function: total bilirubin =60mL/min (calculated by Cockcroft-Gault formula); 11. Women with reproductive potential who had a negative blood or urine pregnancy test within one week prior to enrollment must use effective contraceptive methods after enrollment, such as the use of a physical barrier contraceptive method (condom) or complete abstinence. Oral, injectable or implanted hormonal contraceptives are not permitted. Or women with no reproductive potential, no reproductive potential is defined as: (1) Naturally enter menopause and stop menstruating for more than 1 year; (2) Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); (3) Serum follicle stimulating hormone, luteinizing hormone, and plasma estradiol levels were within the menopause standard of the study center laboratory; 12. Understand the trial procedure and have the ability to follow the trial protocol for the duration of the trial, including cooperating with any treatments, examinations, tests, follow-up and questionnaires required for the completion of the trial; 13. The patient is willing to cooperate with the completion of the questionnaire on the quality of life during the experimental treatment and follow-up, and agrees to use the results of the questionnaire for clinical research; 14. Toxic-side effects from any previous chemotherapy have returned to CTCAE grade 1 or baseline, except for stable sensory neuropathy or alopecia with symptoms <=CTCAE grade 2.
Exclusion criteria
Exclusion criteria: 1. Personnel involved in the formulation or implementation of the research plan; 2. Use other investigational drugs and participate in other clinical drug trials while the study is being conducted; 3. Other neoadjuvant tumor therapies, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine therapy and other experimental therapies, will be used during the study; 4. Known allergy to pamipalide or solfantinib; 5. Inability to swallow oral medications, and any gastrointestinal conditions that may interfere with study drug absorption and metabolism, such as uncontrollable nausea and vomiting, gastrointestinal obstruction, or malabsorption; 6. Have received any anti-cancer treatment related to ovarian cancer; 7. Previous treatment with known or probable PARP inhibitors; 8. Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression; 9. Had major surgery within 3 weeks before the study began or had not recovered from the surgery; 10. The subjects had other malignant diseases within the previous 3 years, except skin squamous cell carcinoma, basal-like carcinoma, ductal carcinoma in situ of breast or cervical carcinoma in situ, which had been effectively treated; 11. The subject has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 12. The subject has a serious, uncontrolled disease or is judged by the investigator to be generally unfit for study participation, including but not limited to: active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; Severe cardiovascular disease, uncontrolled ventricular arrhythmia, or myocardial infarction within the last 3 months; Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that affect the subject's ability to sign informed consent; Hypertension that cannot be controlled by medication; Immunodeficiency (other than splenectomy) or other diseases that the investigator believes may expose the subject to a high risk of toxicity; 13. Any medical history or existing clinical evidence suggests that there is a risk of confusing the study results, interfering with the subject's adherence to the protocol throughout the study treatment period, or that it is not in the best interests of the subject; 14. The subject received platelet or red blood cell infusion within 3 days prior to the study drug initiation; 15. Nursing subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Pathologic complete response, pCR;Disease-free survival at 12 months;12-month survival rate;Adverse event; | — |
Countries
China
Contacts
Public ContactXia Bairong
Anhui Cancer Hospital
Outcome results
None listed