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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Niraparib

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 IV participants with operable diseases; Stage III or IV patients treated with neoadjuvant chemotherapy and interval volume reduction surgery; And stage III patients with significant residual disease after the initial reduction 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

• In stage III patients, the cells were completely reduced after the initial tumor reduction surgery (no residual disease was observed)

• 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