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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 (Jun 2026). This Phase 3 trial studies multiple treatments including Tislelizumab and Capecitabine for rectal neoplasms.

Phase 3RecruitingYong Zhang,MDNCT06017583Data as of Jun 2026Location: China

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

Treatments studied

Immunotherapy

Tislelizumab

Chemotherapy

CapecitabineOxaliplatin

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT06017583 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy, anti-CTLA-4 therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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