Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Exploratory objective:
To evaluate the efficacy of Huaier granule in patients with BRCA mutation and BRCA wild-type ovarian cancer
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huaier granule | Experimental | Huaier granule is supplied as 20-g granule. Huaier granule will be administered as 20 g orally tid x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. In the absence of intolerable toxicity, a patient may continue to receive treatment with Huaier granule until disease progression, or until 24 months have elapsed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier granule | Drug | Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 1 years from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | PFS according to the RECIST 1.1 criteria, based on the investigator's assessment. | 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. |
Not provided
Inclusion Criteria:
≥18years old
Histopathologically confirmed FIGO II-IV stage primary ovarian cancer peritoneal or fallopian tube cancer
Patients who underwent primary tumor reduction or intermediate tumor reduction with satisfactory results (R0/R1) within 15 days after surgery
After tumor reduction, the physician assessed that chemotherapy was not suitable or the patient was unwilling to receive chemotherapy
Life expectancy is 3 months
Liver and kidney function :
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)
Voluntarily participate in the study and sign the informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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. | Every 3 month until 2 years from start of treatment |
| the Rates of AE and SAE | frequency of adverse events according to MedDRA terms | Every 3 month until 2 years from start of treatment |
| D005184 |
| Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |