EUCTR2019-003865-17-AT进行中（未招募）1 期
eoadjuvant CHemoradiotherapy with sequential Ipilimumab and NivOlumab in RECtal cancer (CHINOREC): a prospective randomized, open-label, multicenter, phase II clinical trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 years of age and older
- •All sexes
- •Histologically confirmed carcinoma of the rectum
- •Suitable for local therapy with curative intent
- •Medical need for a standard neoadjuvant CRT
- •Suitable to withstand a course of standard neoadjuvant CRT
- •Written informed consent form (ICF) for participation in the study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Metastatic disease that is considered incurable by local therapies
- •Previous surgery of the tumor other than biopsy
- •Pregnancy, breastfeeding or expectancy to conceive
- •Disagreement of participants with reproductive potential to use
- •contraception throughout the study period and for up to 180 days
- •after the last dose of study therapy
- •Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or
- •any other agent directed against co-inhibitory T cell receptors or
- •has previously participated in clinical studies with immunotherapy
- •Any contraindication according to the official medical information
- •of Ipilimumab or Nivolumab
- •Live vaccine within 30 days prior to the first dose of study therapy
- •Hepatitis B or C
- •Human immunodeficiency virus (HIV)
- •Immunodeficiency
- •Allogeneic tissue or solid organ transplantation
- •Autoimmune disease that has required systemic therapy in the past
- •2 years with modifying agents, steroids or immunosuppressive
- •Systemic steroids or any other form of immunosuppressive therapy
- •within 7 days prior to the first dose of study treatment
- •Active non-infectious pneumonitis
- •Active infection requiring systemic therapy
- •Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
- •Participants with serious or uncontrolled medical disorders
- •Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in
- •females, participants with history of myocarditis)
- •Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to
- •any of the study drugs of the chemotherapy regimen)
- •Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e.
- •infectious disease) illness
- •White blood cells < 2000/µL (SI: < 2.00 × 109/L)
- •Neutrophils < 1500/µL (SI: < 1.50 × 109/L)
- •Platelets < 100 × 103/µL (SI: < 100 × 109/L) (transfusions not
- •permitted within 72 h prior to qualifying laboratory value)
- •Hemoglobin < 9.0 g/dl (SI: < 90 g/L) (transfusions not permitted
- •within 72 h prior to qualifying laboratory value)
- •Serum creatinine > 1.5 × upper limit of normal (ULN) or calculated
- •creatinine clearance < 50 ml/min (using the Cockcroft-Gault
- •AST/ALT: > 3.0 × ULN
- •Total bilirubin > 1.5 × ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of < 3.0 × ULN)
- •Troponin T (TnT) or I (TnI) > 2 × institutional ULN. TnT or TnI levels
- •between > 1 to 2 × ULN will be permitted to participate in the study if a repeat assessment remains 2 × ULN and participant undergoes a cardiac evaluation. When repeat levels within 24 h are not available, a repeat test should be conducted as soon as possible.
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