NCT05597527尚未招募2 期
A Single Arm, Exploratory, Multicenter Clinical Study of Fluzopari Combined With Apatinib Neoadjuvant Therapy in Patients With Advanced Non R0 Resectable Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
This is a single arm, multi center, exploratory clinical study to evaluate the efficacy and safety of fluzoparide combined with alpatinib as neoadjuvant therapy in patients with BRCA1/2 gene mutation or HRD gene mutation, advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and 75 years old;
- •Patients received open surgery, laparoscopic surgery, or coarse needle aspiration biopsy and 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;
- •BRCA1/2 gene mutation or HRD gene mutation is confirmed by testing tissue or blood samples;
- •According to RECIST 1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of CT scan for tumor lesions is ≥ 10mm, the short diameter of CT scan for lymph node lesions is ≥ 15mm, and the scanning thickness is 5mm);
- •Judge the patients who cannot achieve R0 tumor reduction or cannot tolerate surgery. The criteria for failing to achieve R0 tumor reduction include but are not limited to:
- •(1) Fagotti score ≥ 8; (2) When the laparoscopic evaluation method is difficult to implement, the upper abdomen CT score is ≥ 3 (SUDANCT score);
- •The criteria for surgical intolerance are as follows:
- •(3) Body mass index: BMI ≥ 40.0; (4) Various chronic diseases; (5) Malnutrition or hypoproteinemia; (6) Moderate to massive ascites;
- •ECOG PS 0-1 point;
- •The main organs function normally and meet the following standards:
- •The blood routine examination standard shall meet: (no blood transfusion within 14 days)
- •WBC≥3 × 109/L
- •ANC≥1.5 × 109/L，
- •PLT≥100 × 109/L；
- •Biochemical examination shall meet the following standards:
- •BIL ≤ 1.5 times the upper limit of normal value (ULN);
- •ALT and AST ≤ 2.5 × ULN, ALT and AST ≤ 5 in patients with liver metastasis × ULN；
- •Serum Cr ≤ 1.5 × ULN。
- •International normalized ratio (INR) OR prothrombin time (PT), activated partial thrombin activity time (aPTT) ≤ 1.5 × ULN, unless the patient is receiving anticoagulant treatment, as long as PT or aPTT is within the expected treatment range of anticoagulant drugs;
- •There is no obstacle of strict center of gravity, lung, liver and kidney;
- •Women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and 8 weeks after the last administration of the test drug;
- •Estimated total survival time ≥ 6 months, postoperative survival time ≥ 3 months;
- •Sign the written informed consent, and be able to comply with the visit and relevant procedures specified in the scheme.
排除标准
- •Other clinical drug experiments in which other experimental research drugs are used together with the study;
- •In addition to this study, use other cancer neoadjuvant therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbial therapy, traditional Chinese medicine therapy and other experimental treatments;
- •Patients known to be allergic to fluzoparide or allergic to active or non active components of fluzoparide with similar chemical structure;
- •Patients known to be allergic to appatinib or allergic to active or inactive components of drugs with similar chemical structure to appatinib;
- •It is impossible to swallow the oral drug and 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 used known or possible PARP inhibitors and anti vascular production inhibitors in the past;
- •Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment, including but not limited to surgery, radiotherapy and/or corticosteroids, or clinical manifestations of spinal cord compression;
- •Subjects suffered from other malignant diseases in the past 3 years, except skin squamous cell carcinoma, basal like carcinoma, breast intraductal carcinoma in situ or cervical carcinoma in situ;
- •The patient was previously or currently diagnosed as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- •Recently (within 3 months), there has been intestinal obstruction and gastrointestinal perforation;
- •There are clinical cardiac symptoms or diseases that are not well controlled, such as: (1) NYHA level 2 or above cardiac insufficiency (2) unstable angina pectoris (3) acute myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc>470ms;
- •Any bleeding event with a severe grade of 2 or above in CTCAE 5.0 occurred within 4 weeks before the first trial medication;
- •People with hypertension who can not be well controlled after antihypertensive drug treatment (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- •Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organized pneumonia, drug pneumonia, or active pneumonia shown on CT during screening period have been or are currently present;
- •Those with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4s), who have bleeding tendency or are receiving thrombolytic or anticoagulant treatment (including but not limited to patients requiring long-term anticoagulant treatment), are allowed to receive low dose low molecular weight heparin or oral aspirin preventive anticoagulant treatment during the trial;
- •Diagnose patients with deep vein thrombosis (except intermuscular vein thrombosis);
- •People with a history of hereditary or acquired haemorrhagic disease or blood coagulation dysfunction. There were bleeding symptoms with significant clinical significance or clear bleeding tendency within 3 months before the first trial drug use, such as gastrointestinal bleeding, bleeding gastric ulcer, etc;
- •The subject has congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number>the upper limit of normal value);
- •The patient received platelet or red blood cell infusion within four weeks before the start of the study drug treatment;
- •Patients who are pregnant or nursing, or who plan to become pregnant during the study treatment.
研究组 & 干预措施
Fluzopari and Apatinib group
Experimental
Fluzopari and Apatinib were used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose should be strictly controlled according to the experimental design.
干预措施: Fluzopari and apatinib (Drug)
结局指标
主要结局
R0 resection rate
时间窗: 3-month
The percentage of patients received R0 resection after Fluzopari and Apatinib neoadjuvant treatment.
Overall Response Rate (ORR)
时间窗: 3-month
ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.
次要结局
- Disease Control Rate (DCR)(3-month)
- Complete pathologic response rate(CPR)(3-month)
- Progression Free Survival (PFS)(3-year)
- Overall survival (OS)(5 years)
- Incidence rate of adverse events(5 years)
研究者
研究点 (1)
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