XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for MRF-negative Locally Advanced, pMMR Rectal Cancer: a Randomised, Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or pathologically confirmed rectal adenocarcinoma located within 5 to 15cm from the anus with a stage of T3-4a or N+ according to the CT or endoscope
- •Mesorectal fascia uninvolved
- •Sign the informed consent form
- •18 years and older
- •Mismatch repair proficient determined by immunohistochemistry
- •No prior treatment
- •Performance status: ECOG 0-1
- •Good organ function:
- •Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10^9/L, platelet ≥100×10^9/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
- •Unable to swallow or under other circumstance which would drug absorption
- •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
Cadonilimab + XELOX
Oxaliplatin 130 mg/m2 iv and Cadonilimab 10mg/kg iv on day 1； Capecitabine 1000mg/m2 po bid on day 1 to 14； every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
干预措施: Cadonilimab (Drug)
Cadonilimab + XELOX
Oxaliplatin 130 mg/m2 iv and Cadonilimab 10mg/kg iv on day 1； Capecitabine 1000mg/m2 po bid on day 1 to 14； every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
干预措施: Oxaliplatin (Drug)
Cadonilimab + XELOX
Oxaliplatin 130 mg/m2 iv and Cadonilimab 10mg/kg iv on day 1； Capecitabine 1000mg/m2 po bid on day 1 to 14； every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
干预措施: Capecitabine (Drug)
XELOX
Oxaliplatin 130 mg/m2 iv on day 1； Capecitabine 1000mg/m2 po bid on day 1 to 14； every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
干预措施: Oxaliplatin (Drug)
XELOX
Oxaliplatin 130 mg/m2 iv on day 1； Capecitabine 1000mg/m2 po bid on day 1 to 14； every 21 day as a cycle, 4 cycles before surgery and 4 cycles after surgery
干预措施: Capecitabine (Drug)
结局指标
主要结局
pCR
时间窗: 3 years
the rate of pathological complete response
次要结局
- MPR(3 years)
- 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, 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