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OncoMatch/Clinical Trials/NCT06770270

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

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

Phase 2RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT06770270Data as of Jun 2026Location: China

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

Treatments studied

Other

Pucotenlimab

Cancer type

Colorectal Cancer

Disease stage

Required: Stage CT3 OR HIGHER, CN+

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06770270 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage CT3 OR HIGHER or CN+ is required.

Is there an age limit?

Yes. Patients must be 75 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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