huaier granule in patients with stage i primary ovarian fallopian tube cancer after peritoneal cancer

Conditions: Primary Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: this study is an exploratory, single-center, prospective single-arm study to explore the efficacy of huaier granules in the treatment of stage ⅱ-ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (r0/r1). twenty-five patients with figoⅱ-ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with huaier granules. during the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity. this is an exploratory, single-center, prospective single-arm study to explore the efficacy of huaier granules in the treatment of stage ⅱ-ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (r0/r1). twenty-five patients with figoⅱ-ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with huaier granules. during the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity.

primary objective: to evaluate the efficacy of huai er granule in the treatment of stage i primary ovarian cancer, fallopian tube cancer and peritoneal cancer secondary objectives: 1. to analyze the safety of huaier granule in the treatment of ovarian fallopian tube cancer and peritoneal cancer after operation; 2. to analyze the influence of huaier granule on the quality of life of postoperative patients with ovarian fallopian tube cancer and peritoneal cancer exploratory objective: to evaluate the efficacy of huaier granule in patients with brca mutation and brca wild-type ovarian cancer

Eligibility criteria:
inclusion criteria: 1. ≥18years old 2. histopathologically confirmed figo ii-iv stage primary ovarian cancer peritoneal or fallopian tube cancer 3. patients who underwent primary tumor reduction or intermediate tumor reduction with satisfactory results (r0/r1) within 15 days after surgery 4. after tumor reduction, the physician assessed that chemotherapy was not suitable or the patient was unwilling to receive chemotherapy 5. life expectancy is 3 months 6. liver and kidney function : 1. ast and alt 3 times the upper limit of normal value or 5 times the upper limit of normal value in the presence of liver metastasis; t 2. he upper limit of total bilirubin 3 times normal value; 3. serum creatinine is 3 times the upper limit of normal 7. no other tumors, no history of other malignant tumors (except non-melanoma skin cancer in situ cervical cancer or other cancers that have received curative treatment and have no signs of disease for at least 5 years) 8. voluntarily participate in the study and sign the informed consent exclusion criteria: 1. breastfeeding women during pregnancy 2. recurrent ovarian cancer 3. known allergy to the study drug; 4. central nervous system diseases or brain metastases; 5. history of abdominal/pelvic radiotherapy; 6. history of organ transplantation history of immune deficiency disease requiring systemic steroid therapy or other immunosuppressive therapy 7. hiv-ag /ab test result is positive; 8. complicated with serious cardiovascular and cerebrovascular diseases or other serious diseases affecting follow-up treatment of subjects: such as myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; uncontrolled hypertension after antihypertensive therapy (systolic ≥140 or diastolic ≥90 mmhg); uncontrolled diabetes mellitus (hba1c\>8.0%) etc 9. participate in other clinical study patients within 1 month 10. poor compliance is estimated to be difficult to complete the follow-up 11. in addition to the above, the investigator determined that the patients were not suitable for the clinical trial