NCT04282278Unknown2 期
Study of Anti-PD-1 Antibody Multimodal Combination as First-line Treatment on Time Window of Advanced Solid Tumor
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年7月16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
- 180
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to assess time window, efficacy and safety of patients who receive anti-PD-1 antibody multimodal combination as first-line treatment of advanced solid tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age:18 to 70 years old;
- •Patients with advanced solid tumors confirmed by histopathology or cytology and genetic testing was negative;
- •None previous chemotherapy, Antiangiogenic targeted therapy, Immune checkpoint inhibitors therapy（NOTE: neoadjuvant and adjuvant therapy is allowed）;
- •At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Life expectancy greater than or equal to 18 weeks;
- •Major organ function has to meet the following certeria:
- •For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALB≥30g/L ALT and AST<2.5×ULN, but<5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
- •Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
排除标准
- •Patients with symptomatic brain metastases;
- •Subjects with immunosuppressive medications within 14 days of first administration of study treatment, prednisone is used for less than 1 week, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
- •The patient has 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; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- •Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ, dual or multiple primary tumors);
- •Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ;
- •3 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism), in stable phase, need a cardiovascular physician evaluation;
- •Severe infections within 2 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or >38.5℃during screening visits or on the first scheduled day of dosing;
- •History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Less than 4 weeks from the last clinical trial;
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •The researchers think inappropriate.
研究组 & 干预措施
Group A
Experimental
干预措施: Camrelizumab/sintilimab+ Standard chemotherapy (Drug)
Group B
Experimental
干预措施: Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy） (Drug)
Group C
Experimental
干预措施: Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy (Drug)
结局指标
主要结局
PFS
时间窗: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
次要结局
- Adverse events(up to 24 weeks)
- ORR(tumor assessment every 6 weeks since the treatment began，up to 24 months)
- DCR(tumor assessment every 6 weeks since the treatment began，up to 24 months)
- OS(the first day of treatment to death or last survival confirm date,up to 24 months)
研究者
Jian SHI
Principal Investigator
Hebei Medical University Fourth Hospital
研究点 (1)
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