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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Oral administration, 20 g once, 3 times a day, continued until progression or intolerance of toxicity
Progression Free survival (PFS)
PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
Time frame: up to 2 years from start of treatment
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
Time frame: Every 3 month until 2 years from start of treatment
1-year progression-free survival rate
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: From study entry to death or last contact, up to 2 years of follow-up
Quality of life score( EQ-5D)
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questionnaires to be completed by patients and collected frequently during the trial
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Every 3 month until 2 years from start of treatment
the rates of AEs and SAEs
frequency of adverse events according to MedDRA terms
Time frame: up to 2 years