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

NCT05792254 | Unknown

• 1 other identifier: 2023(01)
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression Free survival

  Every 3 month until 2 years from start of treatment

• 1 year overall survival rate

  one year

• Quality of life score（FACT-O）

  Every 3 month until 2 years from start of treatment

• pain score

  Every 3 month until 2 years from start of treatment

• the Rates of AE and SAE

  Every 3 month until 2 years from start of treatment

Study Arms (1)

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.

Drug: Huaier granule

Interventions

Huaier granule DRUG

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

Huaier granule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 31, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2025
• Last Updated: March 31, 2023

Record last verified: 2023-01