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OncoMatch/Clinical Trials/NCT06017583

Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer

Is NCT06017583 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Tislelizumab and Capecitabine for rectal neoplasms.

Phase 3RecruitingYong Zhang,MDNCT06017583Data as of May 2026

Treatment: Tislelizumab · Capecitabine · OxaliplatinThis study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.

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Extracted eligibility criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anti-PD-1 therapy

The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.

Cannot have received: anti-PD-L1 therapy

The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.

Cannot have received: anti-CTLA-4 therapy

The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.

Lab requirements

Blood counts

HB≥90g/L, ANC≥1.5×10^9/L, PLT≥80×10^9/L

Kidney function

plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min

Liver function

TBIL≤1.5 ULN, ALT and AST≤2.5 ULN

blood routine: HB≥90g/L, ANC≥1.5×10^9/L, PLT≥80×10^9/L; Biochemical examination of ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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