Clinical trial NCT05749211: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 59
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression Free survival (PFS)
timeFrame: up to 2 years from start of treatment
Secondary outcomes:
measure: Median Progression Free survival
timeFrame: Every 3 month until 2 years from start of treatment
measure: 1-year progression-free survival rate
timeFrame: up to 1 years
measure: Median overall survival
timeFrame: Every 3 month until 2 years from start of treatment
measure: 1 year overall survival rate
timeFrame: 1 year
measure: overall survival
timeFrame: From study entry to death or last contact, up to 2 years of follow-up
measure: Quality of life score（ EQ-5D）
timeFrame: Every 3 month until 2 years from start of treatment
measure: Quality of life score（EORTC-QLQ-OV28）
timeFrame: Every 3 month until 2 years from start of treatment
measure: Quality of life score（EORTC-QLQ-C30）
timeFrame: Every 3 month until 2 years from start of treatment
measure: Quality of life score（FACT-O）
timeFrame: Every 3 month until 2 years from start of treatment
measure: the rates of AEs and SAEs
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References: