Clinical trial · Interventional
Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer
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
NCT05749211CI-TRIAL-00066468unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Huaier granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Huaier granule
- 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.
- interventionNames
- Drug: Huaier granule
Primary outcomes (1)
- measure
- Progression Free survival (PFS)
- timeFrame
- up to 2 years from start of treatment
- description
- PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
Secondary outcomes (10)
- measure
- Median Progression Free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.