NCT03954756Unknown2 期
Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 主要终点
- Overall survival rate
研究概览
简要总结
The Purpose of This Study is to Evaluate the Efficacy and Safety of Apafitini Combined With PD1 in Patients With Advanced Gastric Cancer After Second-line Treatment Failure, Thus Providing More Options for Patients With Advanced Gastric Cancer.
详细描述
Patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
- •To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed advanced Gastric Cancer.
- •Failure of the second-line standard treatment regimen (disease progression), >14 days from the last chemotherapy, chemotherapy regimen including fluorouracil (5-FU / capecitabine / teggio), oxaliplatin and irinotecan; Acceptable or not received bevacizumab/cetuximab/regofenib treatment.
- •Aged 18-70 years old, both genders.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
- •Life expectancy of at least 3 months.
- •Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.If the lesion receiving local therapy (radiotherapy, radiofrequency, interventional therapy, etc.) is the only lesion, definite imaging progress is required.
- •the main organ functions of the patient shall meet the following standards within 7 days before treatment：Blood routine examination standard (without blood transfusion within 7 days before enrollment）Hemoglobin ≥ 70 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ PLT）≥80×109/L；Biochemical examination shall meet the following standards:serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN)；Serum creatinine (Cr)≤1.5ULN or creatinine removal rate (CCr)≥60ml/min；
- •Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period。
排除标准
- •Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg；
- •Diabetes blood sugar control is poor；
- •Acute phase of cerebral infarction, or recovery period <2 months；
- •Has a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
- •Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion；
- •Coagulation abnormalities （INR>1.5×ULN，APTT>1.5×ULN）,with bleeding tendency;
- •Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation > 1.0 g；
- •Pregnant or lactating women;
- •Within 2 weeks after treatment with cytotoxic drugs and radiotherapy;Has taken two or more oral targeted drugs；
- •Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years；
- •The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request；
- •Patients with severe liver and kidney dysfunction (grade 4) should be excluded;
- •Those who are allergic to any component of apafitini mesylate should be excluded;
- •Mental disorders history, or psychotropic drug abuse history；
- •Previous use of regorafenib is not an exclusion criterion；
- •According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study;
- •Surgery was performed within 4 weeks prior to the start of treatment, or patients with major trauma or fractures. Or there is an unhealed wound before treatment;
- •Patients with severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, or grade III or above (CCS standard) angina, or a history of myocardial infarction within 6 months prior to treatment, or an arrhythmia requiring medication;
- •The patient has brain metastasis, meningeal metastasis;
- •Active HBV infection and rejection of formal antiviral therapy;
- •Active tuberculosis;
- •Participants who have participated in any drug or medical device clinical trial within 1 month prior to the trial.
研究组 & 干预措施
apatinib and PD-1
Experimental
Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect
干预措施: Apatinib and PD1 (Drug)
结局指标
主要结局
Overall survival rate
时间窗: up to 2 year
次要结局
- Objective response rate(up to 2 year)
- Disease control rate(up to 2 year)
- Overall survival(up to 2 year)
研究者
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