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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.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT05815303Data as of May 2026

Treatment: Cadonilimab · Oxaliplatin · CapecitabineThis 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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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