NCT04507750Unknown不适用
A Single-arm, Prospective Clinical Study of Camrelizumab Combined With Apatinib Mesylate in the Treatment of Relapsed Platinum-resistant Epithelial Ovarian Cancer
Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The aim of this study is to explore the effectiveness and safety of camrelizumab combined with apatinib mesylate in the treatment of relapsed platinum-resistant epithelial ovarian cancer
详细描述
The anti-PD-1 drug camrelizumab combined with apatinib mesylate was used to treat relapsed platinum-resistant epithelial ovarian cancer, and the effectiveness and safety of the treatment plan was evaluated by objective remission rate, progression-free survival, and major safety indicators , so as to provide patients a more beneficial treatment plan.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 80 years old;
- •Histologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;
- •Have received at least two lines of systemic chemotherapy;
- •Platinum resistance (disease progression occurs within 6 months after the last platinum-containing chemotherapy Development) or platinum refractory (disease progression during platinum-containing chemotherapy), ovarian cancer,Fallopian tube cancer, primary peritoneal cancer;
- •There are measurable lesions (according to RECIST 1.1 standard tumor lesion CT scan long diameter≥10mm, CT scan of lymph node lesions (short diameter≥ 10mm);
- •ECOG score: 0-1 points;
- •Estimated survival period ≥ 3 months;
- •The main organs function well, and the inspection indicators meet the following requirements:Routine blood examination: hemoglobin ≥90 g/L (no blood transfusion within 14 days); neutrophil count ≥1.5×109/L; platelet count ≥80×109/L; biochemical examination: total bilirubin ≤1.5×ULN ( Upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; endogenous creatinine clearance ≥ 50 ml/min (Cockcroft -Gault formula);
- •The main organs are functioning normally, no blood transfusion or blood products within 14 days;
- •Subjects of childbearing age must agree to take effective contraceptive measures during the trial;Age women's serum or urine pregnancy test must be negative; non-lactating patients;
- •Subjects voluntarily join the study and sign an informed consent form, with good compliance and matchingClose follow-up.
排除标准
- •The subject has any active autoimmune disease or a history of autoimmune disease;
- •Severe allergic reaction to other monoclonal antibodies;
- •Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease;
- •The subject has previously received anti-PD-1, anti-PD-L1, anti-CD137 or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other specific targeting T cell Co-stimulation or checkpoint pathway antibodies or drugs) treatment;
- •Pregnant or breastfeeding women;
- •Patients who have used anti-angiogenesis therapy in the past, including bevacizumab, apatinib, or anlotinib;
- •Participated in other drug clinical trials within three months;
- •There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction, etc.);
- •Any bleeding event with a severity level of CTCAE4.0 or higher in the 4 weeks before screening;
- •Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening;
- •Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); people with a history of unstable angina; a new diagnosis of angina within 3 months before screening Patients or myocardial infarction events occurred within 6 months before screening; Arrhythmia (including QTcF) requires long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ Grade II cardiac insufficiency;
- •Long-term unhealed wounds or fractures with incomplete healing;
- •Have a history of organ transplantation;
- •Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment;
- •Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), those with bleeding tendency (14 days before randomization must meet: INR is normal without using anticoagulants Within the range of values); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; on the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, use for preventive purposes is permitted Low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);
- •Arterial/venous thrombosis events occurred in the year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured by the investigator ) And pulmonary embolism;
- •People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- •According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
- •Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication;
- •Other researchers believe that it is not suitable for inclusion.
研究组 & 干预措施
camrelizumab+apatinib mesylate
Experimental
Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: within 1 year
the proportion of patients with tumor size reduction of a predefined amount
次要结局
- Progression Free Survival(within 1 year)
- 6 months and 12 months overall survival(within 2 year)
- Disease Control Rate(within 1 year)
- drug safety(within 1 year)
研究者
Jing Liang
Professor
Qianfoshan Hospital
研究点 (1)
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