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

NCT ID: NCT05792254

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-05-31

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

Conditions

Primary Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Huaier granule

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.

Group Type: EXPERIMENTAL

Huaier granule

Intervention Type: DRUG

Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.

Interventions

Huaier granule

Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2023(01)

Identifier Type: -

Identifier Source: org_study_id