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

Primary Purpose

Primary Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Huaier granule
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Huaier granule

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Progression Free survival
    PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
    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.
    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
    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.
    the Rates of AE and SAE
    frequency of adverse events according to MedDRA terms

    Full Information

    First Posted
    January 19, 2023
    Last Updated
    March 29, 2023
    Sponsor
    Ruijin Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05792254
    Brief Title
    Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ruijin Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Huaier granule
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Huaier granule
    Intervention Description
    Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.
    Primary Outcome Measure Information:
    Title
    1-year progression-free survival rate
    Description
    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
    Time Frame
    up to 1 years from start of treatment
    Secondary Outcome Measure Information:
    Title
    Progression Free survival
    Description
    PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
    Time Frame
    Every 3 month until 2 years from start of treatment
    Title
    1 year overall survival rate
    Description
    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.
    Time Frame
    one year
    Title
    Quality of life score（FACT-O）
    Description
    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
    Time Frame
    Every 3 month until 2 years from start of treatment
    Title
    pain score
    Description
    In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.
    Time Frame
    Every 3 month until 2 years from start of treatment
    Title
    the Rates of AE and SAE
    Description
    frequency of adverse events according to MedDRA terms
    Time Frame
    Every 3 month until 2 years from start of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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