NCT05815290招募中2 期
A Phase II Trial of Cadonilimab in Locally Advanced Stage II/III MSI-H/dMMR Colorectal Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月29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
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete response rate
研究概览
简要总结
This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment. Eligible patients will receive Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arm 1: Histologically or pathologically confirmed colon adenocarcinoma with a stage of T3-4 or N+ according to the CT or endoscope; Arm 2: Histologically or pathologically confirmed rectal adenocarcinoma located within 12cm from the anus with a stage of T2-4 or N+ according to the CT or endoscope
- •Sign the informed consent form
- •18 years and older
- •Mismatch repair deficient determined by immunohistochemistry or microsatellite instable by PCR
- •No prior treatment
- •Performance status: ECOG 0-1
- •Good organ function:
- •Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10^9/L, platelet ≥80×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL; Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
排除标准
- •Other pathological category, such as squamous cancer
- •Distant metastasis or peritoneum implantation
- •Have received chemotherapy or radiotherapy in the past
- •Known to have allergic reactions to any ingredients or excipients of experimental drugs
- •Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
- •Have received colorectal cancer surgery
- •Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug
- •Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
- •Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
- •Pregnant or nursing
- •May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
- •There are other serious diseases that the researchers believe patients cannot be included in the study
研究组 & 干预措施
dMMR/MSI-H colon cancer
Experimental
干预措施: Cadonilimab (Drug)
dMMR/MSI-H rectal cancer
Experimental
干预措施: Cadonilimab (Drug)
结局指标
主要结局
complete response rate
时间窗: 3 years
For colon cancer arm, complete response rate include the rate of pathological complete response and clinical complete response; for rectal cancer arm, complete response rate means the rate of clinical complete response
次要结局
- pCR rate(2 year)
- DFS(From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 3 years)
- OS(From date of initiation of treatment to date of death due to any cause, assessed up to 3 years)
研究者
AIPING ZHOU
Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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