OncoMatch

OncoMatch/Clinical Trials/NCT06770270

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)

Is NCT06770270 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pucotenlimab for rectal cancer.

Phase 2RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT06770270Data as of May 2026

Treatment: PucotenlimabColorectal cancer is a common gastrointestinal tumor, with rising incidence in China. Rectal cancer accounts for nearly half of new cases, and many patients are diagnosed at a locally advanced stage. Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment, but only 20-30% achieve a complete response, with many experiencing recurrence or metastasis. Immunotherapy, particularly PD-1/PD-L1 inhibitors, has shown promise in improving outcomes, especially in dMMR/MSI-H patients. However, most rectal cancer patients have MSS, where combining immunotherapy with nCRT has shown moderate success in clinical trials. This project aims to explore the safety and efficacy of PD-1 inhibitor (pucotenlimab) combined with nCRT for locally advanced rectal cancer, potentially offering new treatment options.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage CT3 OR HIGHER, CN+

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: any anti-tumor treatment for rectal cancer

Exception: traditional chinese medicine treatments

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥10 g/dL; Serum albumin ≥3.0 g/dL

Kidney function

Serum creatinine ≤ ULN or creatinine clearance rate ≥60 mL/min

Liver function

Total bilirubin ≤ ULN, ALT, AST, and/or AKP ≤2.5 × ULN

Major organs or functions meet the following criteria (within 2 weeks before the test, no use of any blood components or growth factors for correction is allowed): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥10 g/dL; Serum albumin ≥3.0 g/dL; Total bilirubin ≤ ULN, ALT, AST, and/or AKP ≤2.5 × ULN; Serum creatinine ≤ ULN or creatinine clearance rate ≥60 mL/min; International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ ULN;

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

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