Fallopian Tube Cancer, Peritoneal Cancer, Primary Ovarian Cancer
Conditions
Brief 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.
Detailed description
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
Interventions
DRUGHuaier granule
Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year progression-free survival rate | up to 1 years from start of treatment | The time from study entry to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free survival | Every 3 month until 2 years from start of treatment | PFS according to the RECIST 1.1 criteria, based on the investigator's assessment. |
| 1 year overall survival rate | one year | Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol. |
| Quality of life score（FACT-O） | Every 3 month until 2 years from start of treatment | The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section |
| pain score | Every 3 month until 2 years from start of treatment | In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain. |
| the Rates of AE and SAE | Every 3 month until 2 years from start of treatment | frequency of adverse events according to MedDRA terms |
Outcome results
None listed