OncoMatch/Clinical Trials/NCT05815303
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer
Is NCT05815303 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cadonilimab and Oxaliplatin for rectal cancer.
Treatment: Cadonilimab · Oxaliplatin · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Have received chemotherapy or radiotherapy in the past
Cannot have received: radiation therapy
Have received chemotherapy or radiotherapy in the past
Cannot have received: surgery
Have received colorectal cancer surgery
Lab requirements
Blood counts
hemoglobin ≥90g/L, neutrophil ≥1.5×10^9/L, platelet ≥100×10^9/L
Kidney 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
Cardiac function
Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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