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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huaier granule | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier granule | Drug | Oral administration, 20 g once, 3 times a day, continued until progression or intolerance of toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival (PFS) | PFS according to the RECIST 1.1 criteria, based on the investigator's assessment. | up to 2 years from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free survival | mPFS is defined as the median time from study entry to date of first documented objective tumor recurrence according to RECIST 1.1 | Every 3 month until 2 years from start of treatment |
| 1-year progression-free survival rate |
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Inclusion Criteria:
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 had been diagnosed and/or treated for invasive cancer less than 5 years prior to enrollment
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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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 |
| up to 1 years |
| Median overall survival | 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 | Every 3 month until 2 years from start of treatment |
| 1 year overall survival rate | 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 | OS is defined as the time from start of treatment to date of death due to any cause, or last patient contact | From study entry to death or last contact, up to 2 years of follow-up |
| Quality of life score( EQ-5D) | questionnaires to be completed by patients and collected frequently during the trial | Every 3 month until 2 years from start of treatment |
| Quality of life score(EORTC-QLQ-OV28) | Assessment of quality of life according to the QLQ-OV28/EORTC scales | Every 3 month until 2 years from start of treatment |
| Quality of life score(EORTC-QLQ-C30) | Assessment of quality of life according to the QLQ-C30/EORTC scales | Every 3 month until 2 years from start of treatment |
| Quality of life score(FACT-O) | 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 | Every 3 month until 2 years from start of treatment |
| the rates of AEs and SAEs | frequency of adverse events according to MedDRA terms | up to 2 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |