NCT04303130Unknown2 期
Camrelizumab (SHR-1210) Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous Non-small Cell Lung Cancer (NSCLC)
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年12月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PFS (Progression-Free survival)
研究概览
简要总结
This study is a single-arm, prospective, multi-center clinical trial. designed to evaluate patients with stage IV inability to receive or refuse chemotherapy.Efficacy and safety of first-line treatment with Camrelizumab and Endo in advanced lung squamous cell carcinoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects >/= 18 years of age at the time of Informed Consent.
- •Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) have a histologically or cytologically confirmed stage IV (American Joint Committee on Cancer [AJCC] 8th edition) , and the stage IIIB/IIIC SqNSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy.
- •.No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
- •Life expectancy of at least three months.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm, the short diameter of CT scan of the lymph node lesions > 15 mm).
- •The main organ function is normal. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria.
- •Hemoglobin ≥ 9.0 g/dL (90 g/L)
- •Absolute neutrophil count ≥ 2× 109/L
- •Platelets ≥ 100× 109/L
- •Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); alkaline phosphatase ≤ 5 × ULN
- •Serum creatinine ≤ 1× ULN or creatinine clearance > 60 mL/minute (using Cockcroft/Gault formula)
- •Subject dosen't have unhealed wounds before enrollment.
- •Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 60 days (about 5 drug half-life + menstrual cycle) after the last dose of SHR-
- •Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barriermethods of contraception from screening through 120 days (about 5 drug half-life + sperm depletion cycle) after the last dose of SHR-
- •Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
- •Exclusion Criteria
- •Active central nervous system (CNS) metastasis and/or cancerous meningitis. Patients with treated brain metastases who were clinically stable for at least 2 weeks and have no new or advanced brain metastases may be enrolled. Patients with known untreated, asymptomatic brain metastases can be enrolled provided cerebral imaging assessment be regularly performed.
- •Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
- •Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. Subjects with uncontrolled hypertension.
- •Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function).
- •subjects with childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included .
- •Participants who had abnormal blood coagulation (INR>1.5 or PT> ULN+4s, and or APTT > 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulation；
- •Urine routine indicates urinary protein ≥ ++, or confirms that 24-hour urine protein is ≥1.0 g；
- •Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
- •The patient has severe infection within 4 weeks before first administration（such as the need for intravenous antibiotics, antifungals or antivirals) and unexplained fever within 7 days before administration, ≥38.5 °C
- •There was significant coughing blood and significant clinically significant bleeding symptoms or a clear tendency to hemorrhage in the first 2 months before enrollment (such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above at baseline, or suffering from vasculitis, etc.).
- •Serious Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within 12 months before enrollment.
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA ≥ 500 IU/mL ; HVC: HCV RNA positive and abnormal liver function). And subjects with active tuberculosis.
- •History of severe hypersensitivity reactions to any component contained in Endostar or antibody preparation of Camrelizumab. And known to have severe allergic reactions to infusion reactions.
- •Any known mental illness or substance abuse that may have an impact on compliance with the test requirements;
- •There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
排除标准
- 未提供
研究组 & 干预措施
Camrelizumab (SHR-1210) Combined With Endostar
Experimental
Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance.
The combination regimen is a medication cycle every three weeks (21 days).
干预措施: Camrelizumab (Drug)
结局指标
主要结局
PFS (Progression-Free survival)
时间窗: 1 Year
From the date Into this study (signed ICF) to tumor progression or death for any
One year survival rate
时间窗: 1 Year
次要结局
- DOR(Duration of response）(From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.)
- ORR (Objective control rate)(From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.)
- DCR (Disease control rate)(From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.)
研究者
Jian Fang
Director,Head of thoracic oncology
Peking University Cancer Hospital & Institute
研究点 (1)
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