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

Shanghai Jiao Tong University

Status: Not yet enrolling

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

Treatments: Drug: Huaier granule

Study type: Interventional

Funder types: Other

Identifiers

NCT05792254

2023(01)

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Huaier granule

Experimental group

Description:

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.

Treatment:

Drug: Huaier granule