NCT04124601已完成2 期
Neoadjuvant CHemoradiotherapy With Sequential Ipilimumab and NivOlumab in RECtal Cancer (CHINOREC): a Prospective Randomized, Open-label, Multicenter, Phase II Clinical Trial
Johannes Laengle, MD, PhD5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
This prospective randomized, open-label, multicenter, phase II clinical trial investigates the safety and tolerability of standard neoadjuvant chemoradiotherapy (CRT) with sequential ipilimumab and nivolumab in rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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 drugs
- •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 formula)
- •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.
研究组 & 干预措施
Neoadjuvant Chemoradiotherapy
Other
Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)
干预措施: Chemoradiotherapy (Radiation)
Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab
Experimental
Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)
干预措施: Chemoradiotherapy (Radiation)
Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab
Experimental
Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)
干预措施: Ipilimumab (Drug)
Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab
Experimental
Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)
干预措施: Nivolumab (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: 20 weeks
Incidence of treatment-emergent adverse events will be assessed according to the latest "Clavien- Dindo Classification of surgical complications" and Common Terminology Criteria of Adverse Events (CTCAE).
次要结局
- Radiographic therapy response between pre-and post-neoadjuvant treatment(20 weeks)
- Pathologic therapy response to neoadjuvant treatment(20 weeks)
研究者
Johannes Laengle, MD, PhD
Sponsor-Investigator
Medical University of Vienna
研究点 (5)
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