| Eligibility |
Inclusion Criteria:
- Before any procedure of the test is started, informed consent must be provided and
filed in the research center.
- Female subjects = 18 years of age.
- Biopsy obtained by open surgery, laparoscopic surgery or thick needle puncture,
pathologically confirmed as high-grade serous or endometrioid ovarian cancer,
peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian
cancer), FIGO stage III-IV.
- Detect tissue samples or blood samples through a testing agency designated by the
research center to determine the HRR-related gene mutation or HRD mutation status of
patients.
- The blood and tissue samples of patients before, during, and after treatment can be
obtained, and the subjects agree to submit the blood and tissue samples to the Center
for the expanded research purpose of the trial, such as possible gene-related research
or tumor marker related research.
- At least one lesion can be measured by CT/MRI.
- The professional gynecological oncologists appointed by each center should judge the
patients who can not achieve R0 tumor reduction or can not tolerate surgery.
- The criteria for failure to achieve R0 tumor reduction include but are not limited
to:Fagotti endoscopic score = 8 points;When the laparoscopic evaluation method is
difficult to implement, the upper abdomen CT score can be = 3 points;
- The judgment criteria of intolerable surgery can consider:Body mass index: BMI =
40.0;Multiple chronic diseases;Malnutrition or hypoproteinemia Moderate to massive
ascites;Newly diagnosed venous thromboembolism (except intermuscular venous
thrombosis) (survival time greater than 12 weeks).
- Expected survival time > 12 weeks.
- The patient's ECOG score is 0-2.
- Good organ function, including:Bone marrow function: neutrophil count = 1500/µ L;
Platelet = 100000/µ L; Hemoglobin = 10g/dL;Liver function: total bilirubin = 1.5 times
the upper limit of normal value or direct bilirubin = 1.0 times the upper limit of
normal value; AST and ALT = 2.5 times the upper limit of normal value, and when liver
metastasis exists, it must be = 5 times the upper limit of normal value Renal
function: serum creatinine = 1.5 times the upper limit of normal value, or creatinine
clearance rate = 60mL/min (calculated according to Cockcroft Gault formula).
- For women with fertility potential, the blood test or urine pregnancy test was
negative within one week before enrollment. After enrollment, effective contraceptive
measures must be taken, such as using physical barrier contraceptive methods (condoms)
or complete abstinence; Oral, injectable, or implanted hormonal contraceptives are not
allowed.
Exclusion Criteria:
- Personnel involved in the formulation or implementation of the research plan.
- Use other experimental research drugs and participate in other clinical drug
experiments while the study is being conducted.
- At the same time of the study, use other new adjuvant therapies for tumors, including
but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy,
traditional Chinese medicine, and other experimental therapies.
- People who are known to be allergic to active or inactive ingredients of Pamiparib,
Surufatinib or drugs with similar chemical structures to the two drugs.
- Unable to swallow the oral drug, and suffering from any gastrointestinal disease that
may interfere with the absorption and metabolism of the study drug, such as
uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption.
- Have received any anti-cancer treatment related to ovarian cancer.
- Have received known or possible PARP inhibitor treatment in the past.
- Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment,
including but not limited to surgery, radiation and/or corticosteroids, or clinical
manifestations of spinal cord compression.
- Major surgery was performed within 3 weeks before the start of the study, or it has
not recovered after surgery.
- Subjects had other malignant diseases in the past 3 years, except for effectively
treated skin squamous cell carcinoma, basal-like carcinoma, breast intraductal
carcinoma in situ or cervical carcinoma in situ.
- The patient has myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
previously or currently diagnosed.
- Suffering from serious and uncontrollable diseases or the investigator judged that the
subject was generally not suitable for the study, including but not limited to: active
virus infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.;
Severe cardiovascular disease, uncontrollable ventricular arrhythmia, and myocardial
infarction in the last 3 months; Uncontrolled seizures, unstable spinal cord
compression, superior vena cava syndrome or other mental disorders that affect the
patient's informed consent; Hypertension beyond drug control; Immune deficiency
(excluding splenectomy) or other diseases that the researchers believe may expose the
patient to high-risk toxicity.
- Any medical history or existing clinical evidence indicates that there may be
circumstances that may confuse the study results, interfere with patients' compliance
with the trial protocol during the whole study treatment period or are not in the best
interests of patients.
- The patient received platelet or red blood cell infusion within 3 days before the
start of treatment of the study drug.
- Patients who are pregnant or nursing, or who are expected to become pregnant during
the study treatment.
- There are unresolved previous treatment toxicity (= grade 2, excluding alopecia,
neuralgia, lymphocytopenia, and depigmentation of skin) in clinic.
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