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Trial Title:
Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer
NCT ID:
NCT05792254
Condition:
Primary Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Conditions: Official terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier granule
Description:
Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance
toxicity.
Arm group label:
Huaier granule
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
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792254
