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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.
1-year progression-free survival rate
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
Time frame: up to 1 years from start of treatment
Progression Free survival
PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
Time frame: Every 3 month until 2 years from start of treatment
1 year overall survival rate
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.
Time frame: one year
Quality of life score(FACT-O)
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
Time frame: Every 3 month until 2 years from start of treatment
pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.
Time frame: Every 3 month until 2 years from start of treatment
the Rates of AE and SAE
frequency of adverse events according to MedDRA terms
Time frame: Every 3 month until 2 years from start of treatment
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