Ovarian Cancer
Conditions
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.
Interventions
DRUGHuaier granule
Oral administration, 20 g once, 3 times a day, continued until progression or intolerance of toxicity
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free survival (PFS) | up to 2 years from start of treatment | PFS according to the RECIST 1.1 criteria, based on the investigator's assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year progression-free survival rate | up to 1 years | The time from study entry to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause |
| Median overall survival | Every 3 month until 2 years from start of treatment | Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol |
| 1 year overall survival rate | 1 year | Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol. |
| overall survival | From study entry to death or last contact, up to 2 years of follow-up | OS is defined as the time from start of treatment to date of death due to any cause, or last patient contact |
| Median Progression Free survival | Every 3 month until 2 years from start of treatment | mPFS is defined as the median time from study entry to date of first documented objective tumor recurrence according to RECIST 1.1 |
| Quality of life score（EORTC-QLQ-OV28） | Every 3 month until 2 years from start of treatment | Assessment of quality of life according to the QLQ-OV28/EORTC scales |
| Quality of life score（EORTC-QLQ-C30） | Every 3 month until 2 years from start of treatment | Assessment of quality of life according to the QLQ-C30/EORTC scales |
| Quality of life score（FACT-O） | Every 3 month until 2 years from start of treatment | The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section |
| the rates of AEs and SAEs | up to 2 years | frequency of adverse events according to MedDRA terms |
| Quality of life score（ EQ-5D） | Every 3 month until 2 years from start of treatment | questionnaires to be completed by patients and collected frequently during the trial |
Outcome results
None listed