Pamiparib Combined With Surufatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT05652283
- Lead Sponsor
- Bai-Rong Xia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 37
Inclusion Criteria:<br><br> - Before any procedure of the test is started, informed consent must be provided and<br> filed in the research center.<br><br> - Female subjects = 18 years of age.<br><br> - Biopsy obtained by open surgery, laparoscopic surgery or thick needle puncture,<br> pathologically confirmed as high-grade serous or endometrioid ovarian cancer,<br> peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian<br> cancer), FIGO stage III-IV.<br><br> - Detect tissue samples or blood samples through a testing agency designated by the<br> research center to determine the HRR-related gene mutation or HRD mutation status of<br> patients.<br><br> - The blood and tissue samples of patients before, during, and after treatment can be<br> obtained, and the subjects agree to submit the blood and tissue samples to the<br> Center for the expanded research purpose of the trial, such as possible gene-related<br> research or tumor marker related research.<br><br> - At least one lesion can be measured by CT/MRI.<br><br> - The professional gynecological oncologists appointed by each center should judge the<br> patients who can not achieve R0 tumor reduction or can not tolerate surgery.<br><br> - The criteria for failure to achieve R0 tumor reduction include but are not limited<br> to:Fagotti endoscopic score = 8 points;When the laparoscopic evaluation method is<br> difficult to implement, the upper abdomen CT score can be = 3 points;<br><br> - The judgment criteria of intolerable surgery can consider:Body mass index: BMI =<br> 40.0;Multiple chronic diseases;Malnutrition or hypoproteinemia Moderate to massive<br> ascites;Newly diagnosed venous thromboembolism (except intermuscular venous<br> thrombosis) (survival time greater than 12 weeks).<br><br> - Expected survival time > 12 weeks.<br><br> - The patient's ECOG score is 0-2.<br><br> - Good organ function, including:Bone marrow function: neutrophil count = 1500/µ L;<br> Platelet = 100000/µ L; Hemoglobin = 10g/dL;Liver function: total bilirubin = 1.5<br> times the upper limit of normal value or direct bilirubin = 1.0 times the upper<br> limit of normal value; AST and ALT = 2.5 times the upper limit of normal value, and<br> when liver metastasis exists, it must be = 5 times the upper limit of normal value<br> Renal function: serum creatinine = 1.5 times the upper limit of normal value, or<br> creatinine clearance rate = 60mL/min (calculated according to Cockcroft Gault<br> formula).<br><br> - For women with fertility potential, the blood test or urine pregnancy test was<br> negative within one week before enrollment. After enrollment, effective<br> contraceptive measures must be taken, such as using physical barrier contraceptive<br> methods (condoms) or complete abstinence; Oral, injectable, or implanted hormonal<br> contraceptives are not allowed.<br><br>Exclusion Criteria:<br><br> - Personnel involved in the formulation or implementation of the research plan.<br><br> - Use other experimental research drugs and participate in other clinical drug<br> experiments while the study is being conducted.<br><br> - At the same time of the study, use other new adjuvant therapies for tumors,<br> including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial<br> therapy, traditional Chinese medicine, and other experimental therapies.<br><br> - People who are known to be allergic to active or inactive ingredients of Pamiparib,<br> Surufatinib or drugs with similar chemical structures to the two drugs.<br><br> - Unable to swallow the oral drug, and suffering from any gastrointestinal disease<br> that may interfere with the absorption and metabolism of the study drug, such as<br> uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption.<br><br> - Have received any anti-cancer treatment related to ovarian cancer.<br><br> - Have received known or possible PARP inhibitor treatment in the past.<br><br> - Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment,<br> including but not limited to surgery, radiation and/or corticosteroids, or clinical<br> manifestations of spinal cord compression.<br><br> - Major surgery was performed within 3 weeks before the start of the study, or it has<br> not recovered after surgery.<br><br> - Subjects had other malignant diseases in the past 3 years, except for effectively<br> treated skin squamous cell carcinoma, basal-like carcinoma, breast intraductal<br> carcinoma in situ or cervical carcinoma in situ.<br><br> - The patient has myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)<br> previously or currently diagnosed.<br><br> - Suffering from serious and uncontrollable diseases or the investigator judged that<br> the subject was generally not suitable for the study, including but not limited to:<br> active virus infection, such as human immunodeficiency virus, hepatitis B, hepatitis<br> C, etc.; Severe cardiovascular disease, uncontrollable ventricular arrhythmia, and<br> myocardial infarction in the last 3 months; Uncontrolled seizures, unstable spinal<br> cord compression, superior vena cava syndrome or other mental disorders that affect<br> the patient's informed consent; Hypertension beyond drug control; Immune deficiency<br> (excluding splenectomy) or other diseases that the researchers believe may expose<br> the patient to high-risk toxicity.<br><br> - Any medical history or existing clinical evidence indicates that there may be<br> circumstances that may confuse the study results, interfere with patients'<br> compliance with the trial protocol during the whole study treatment period or are<br> not in the best interests of patients.<br><br> - The patient received platelet or red blood cell infusion within 3 days before the<br> start of treatment of the study drug.<br><br> - Patients who are pregnant or nursing, or who are expected to become pregnant during<br> the study treatment.<br><br> - There are unresolved previous treatment toxicity (= grade 2, excluding alopecia,<br> neuralgia, lymphocytopenia, and depigmentation of skin) in clinic.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) After Neoadjuvant treatment;Pathological complete remission rate;12-month disease-free survival rate;12-month survival rate