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Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer

Primary Purpose

Ovarian 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 Ovarian Cancer

Eligibility Criteria

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

Inclusion Criteria: According to FIGO criteria, participants must have a histological diagnosis of high-grade serous or endometrioid carcinoma, or high-grade serous or endometrioid predominantly ovarian, fallopian tube cancer, or stage III or IV primary peritoneal carcinoma Inoperable stage III and IV patients; All stage III and IV patients who can accept initial or intermittent tumor reduction surgery, regardless of the residual lesion status after surgery Patients who had undergone abdominal chemotherapy; All participants must undergo 6 and 9 cycles of platinum-based therapy; Participants were required to receive 2 cycles of postoperative platinum therapy following interphase tumor reduction surgery; Participants had to be assessed by a physician for complete response (CR) or partial response (PR) after 3 cycles of treatment; Participants had to have cancer antigen 125 (CA-125) within the normal range or ca-125 decreased by more than 90%(%) to be stable during their first-line therapy All participants must agree to be tested for central tumor BRCA Fertile participants must have a negative serum or urine pregnancy test (human chorionic gonadotropin [hCG]) within 7 days of receiving the first dose of study treatment. Exclusion Criteria: Participants had epithelial ovarian carcinosarcoma or mucinous or clear cell subtypes of undifferentiated ovarian cancer The participants had already undergone more than two tumor-reduction surgeries for the study disease Participants became pregnant or lactated or expected to become pregnant during study treatment and 180 days after the last dose of study treatment Participants were known to be allergic to the ingredients or excipients of the study drug Participants had previously been treated with a known PARP inhibitor or had participated in any treatment group that included the use of a known PARP inhibitor Participants received bevacizumab maintenance therapy Subjects received investigational therapy within 4 weeks or at intervals not exceeding 5 investigational drug half-lives, whichever is longer, prior to the study's first scheduled dosing date Participants had known grade 3 anemia, neutropenia or thrombocytopenia that persisted due to prior chemotherapy. 4 weeks; Throughout the study treatment period, participants were treated with conditions (such as transfusion-dependent anemia or thrombocytopenia) or laboratory abnormalities that could confound study results or interfere with their participation, including: Participants received blood transfusions (platelets or red blood cells) within 2 weeks of the first dose of study treatment Participants received colony stimulating factor (e.g., granulocyte-colony-stimulating factor [G-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment; Participants had been diagnosed and/or treated for invasive cancer less than 5 years prior to enrollment

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

    Progression Free survival (PFS)
    PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.

    Secondary Outcome Measures

    Median Progression Free survival
    mPFS is defined as the median time from study entry to date of first documented objective tumor recurrence according to RECIST 1.1
    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
    Median overall survival
    Median 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
    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.
    overall survival
    OS is defined as the time from start of treatment to date of death due to any cause, or last patient contact
    Quality of life score( EQ-5D)
    questionnaires to be completed by patients and collected frequently during the trial
    Quality of life score(EORTC-QLQ-OV28)
    Assessment of quality of life according to the QLQ-OV28/EORTC scales
    Quality of life score(EORTC-QLQ-C30)
    Assessment of quality of life according to the QLQ-C30/EORTC scales
    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
    the rates of AEs and SAEs
    frequency of adverse events according to MedDRA terms

    Full Information

    First Posted
    January 19, 2023
    Last Updated
    May 15, 2023
    Sponsor
    Ruijin Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05749211
    Brief Title
    Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer
    Official Title
    Efficacy and Safety of Huaier Granule in Combination With Nilaparil in First-line Maintenance Therapy in Postoperative Patients With Stage III/IV BRCA Wild-type Ovarian 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
    December 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

    5. Study Description

    Brief Summary
    This is a single-center, prospective, single-arm clinical trial to evaluate the efficacy and safety of Huaier granules in combination with immunotargeted agents in postoperative patients with ovarian cancer.
    Detailed Description
    Primary objective : 1) To evaluate the efficacy of Huaier granule combined with immunotargeted drugs in the treatment of postoperative ovarian cancer patients Secondary objectives: 1)To analyze the safety of Huaier granule in the treatment of postoperative ovarian cancer patients; 2)2) To analyze the influence of Huaier granule on postoperative quality of life of patients with ovarian cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian 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
    59 (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
    Other Intervention Name(s)
    Niraparib
    Intervention Description
    Oral administration, 20 g once, 3 times a day, continued until progression or intolerance of toxicity
    Primary Outcome Measure Information:
    Title
    Progression Free survival (PFS)
    Description
    PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
    Time Frame
    up to 2 years from start of treatment
    Secondary Outcome Measure Information:
    Title
    Median Progression Free survival
    Description
    mPFS is defined as the median time from study entry to date of first documented objective tumor recurrence according to RECIST 1.1
    Time Frame
    Every 3 month until 2 years from start of treatment
    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
    Title
    Median overall survival
    Description
    Median 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
    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
    1 year
    Title
    overall survival
    Description
    OS is defined as the time from start of treatment to date of death due to any cause, or last patient contact
    Time Frame
    From study entry to death or last contact, up to 2 years of follow-up
    Title
    Quality of life score( EQ-5D)
    Description
    questionnaires to be completed by patients and collected frequently during the trial
    Time Frame
    Every 3 month until 2 years from start of treatment
    Title
    Quality of life score(EORTC-QLQ-OV28)
    Description
    Assessment of quality of life according to the QLQ-OV28/EORTC scales
    Time Frame
    Every 3 month until 2 years from start of treatment
    Title
    Quality of life score(EORTC-QLQ-C30)
    Description
    Assessment of quality of life according to the QLQ-C30/EORTC scales
    Time Frame
    Every 3 month until 2 years from start of treatment
    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
    the rates of AEs and SAEs
    Description
    frequency of adverse events according to MedDRA terms
    Time Frame
    up to 2 years

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: According to FIGO criteria, participants must have a histological diagnosis of high-grade serous or endometrioid carcinoma, or high-grade serous or endometrioid predominantly ovarian, fallopian tube cancer, or stage III or IV primary peritoneal carcinoma Inoperable stage III and IV patients; All stage III and IV patients who can accept initial or intermittent tumor reduction surgery, regardless of the residual lesion status after surgery Patients who had undergone abdominal chemotherapy; All participants must undergo 6 and 9 cycles of platinum-based therapy; Participants were required to receive 2 cycles of postoperative platinum therapy following interphase tumor reduction surgery; Participants had to be assessed by a physician for complete response (CR) or partial response (PR) after 3 cycles of treatment; Participants had to have cancer antigen 125 (CA-125) within the normal range or ca-125 decreased by more than 90%(%) to be stable during their first-line therapy All participants must agree to be tested for central tumor BRCA Fertile participants must have a negative serum or urine pregnancy test (human chorionic gonadotropin [hCG]) within 7 days of receiving the first dose of study treatment. Exclusion Criteria: Participants had epithelial ovarian carcinosarcoma or mucinous or clear cell subtypes of undifferentiated ovarian cancer The participants had already undergone more than two tumor-reduction surgeries for the study disease Participants became pregnant or lactated or expected to become pregnant during study treatment and 180 days after the last dose of study treatment Participants were known to be allergic to the ingredients or excipients of the study drug Participants had previously been treated with a known PARP inhibitor or had participated in any treatment group that included the use of a known PARP inhibitor Participants received bevacizumab maintenance therapy Subjects received investigational therapy within 4 weeks or at intervals not exceeding 5 investigational drug half-lives, whichever is longer, prior to the study's first scheduled dosing date Participants had known grade 3 anemia, neutropenia or thrombocytopenia that persisted due to prior chemotherapy. 4 weeks; Throughout the study treatment period, participants were treated with conditions (such as transfusion-dependent anemia or thrombocytopenia) or laboratory abnormalities that could confound study results or interfere with their participation, including: Participants received blood transfusions (platelets or red blood cells) within 2 weeks of the first dose of study treatment Participants received colony stimulating factor (e.g., granulocyte-colony-stimulating factor [G-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment; Participants had been diagnosed and/or treated for invasive cancer less than 5 years prior to enrollment

    12. IPD Sharing Statement

    Learn more about this trial

    Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer

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