huaier granule in combination with nilaparil in therapy patients with stage iii/iv brca wild-type ovarian cancer

Conditions: Ovarian Cancer

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.

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.

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