Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer

Study Overview
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Brief Summary
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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
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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: To analyze the safety of Huaier granule in the treatment of ovarian fallopian tube cancer and peritoneal cancer after operation; 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

Official Title
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Efficacy and Safety of Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer: a Single-center Prospective Single-arm Study

Conditions
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Primary Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: Huaier granule


Participation Criteria
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Eligibility Criteria
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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 : 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 he upper limit of total bilirubin 3 times normal value; Serum creatinine is 3 times the upper limit of normal 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: Breastfeeding women during pregnancy Recurrent ovarian cancer Known allergy to the study drug; Central nervous system diseases or brain metastases; History of abdominal/pelvic radiotherapy; History of organ transplantation history of immune deficiency disease requiring systemic steroid therapy or other immunosuppressive therapy Hiv-ag /AB test result is positive; 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 Participate in other clinical study patients within 1 month Poor compliance is estimated to be difficult to complete the follow-up In addition to the above, the investigator determined that the patients were not suitable for the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huaier granule<br>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. | Drug: Huaier granule<br>* Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |