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Trial Title:
Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer
NCT ID:
NCT05749211
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Niraparib
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 administration, 20 g once, 3 times a day, continued until progression or intolerance
of toxicity
Arm group label:
Huaier granule
Other name:
Niraparib
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.
Criteria for 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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 2023
Completion date:
December 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/NCT05749211
