XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer
Rectal Cancer, MSS
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Cadonilimab + XELOX
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
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