OncoMatch/Clinical Trials/NCT07448142
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
Is NCT07448142 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pucotenlimab and CAPEOX/XELOX for colorectal cancer (crc).
Treatment: Pucotenlimab · CAPEOX/XELOX — This is a prospective, open-label, randomized, parallel-group phase II trial evaluating the efficacy and safety of a low-dose radiotherapy sensitization strategy combined with a PD-1 antibody (pucotenlimab) and CAPEOX as neoadjuvant therapy in patients with pMMR/MSS locally advanced rectal adenocarcinoma. Participants will be randomized 1:1 to receive either 2 Gy or 5 Gy low-dose radiotherapy. Low-dose radiotherapy is delivered as a single fraction of 2 Gy (Arm A) or 5 Gy (Arm B). On the day after radiotherapy, participants will start pucotenlimab 200 mg IV Q3W (administered on Day 2 of each 21-day cycle) plus CAPEOX chemotherapy. Early response will be assessed after 2 cycles using endoscopy and pelvic MRI to guide subsequent treatment: participants with partial response may discontinue radiotherapy and continue neoadjuvant systemic therapy; participants with stable disease may switch to standard chemoradiotherapy; participants with progressive disease will receive multidisciplinary-team-guided salvage therapy. After 4 cycles, participants with clinical complete response may adopt a watch-and-wait strategy; otherwise, they will undergo radical surgery 2-4 weeks after completion of neoadjuvant therapy. Long-term follow-up will include recurrence and survival outcomes and quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T2N+
Locally advanced disease, defined as clinical stage T2N+ or T3-T4a (any N) based on pelvic magnetic resonance imaging (MRI). Clinical T4b disease, defined as tumor invasion into adjacent organs or structures on baseline imaging [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: pelvic or abdominal radiotherapy
Prior pelvic or abdominal radiotherapy
Cannot have received: immune checkpoint inhibitor
Prior treatment with immune checkpoint inhibitors or other systemic anticancer therapy for rectal cancer
Cannot have received: systemic anticancer therapy
Prior treatment with immune checkpoint inhibitors or other systemic anticancer therapy for rectal cancer
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥90 g/L
Kidney function
Creatinine clearance ≥50 mL/min
Liver function
Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN
Adequate organ function as defined by: Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥90 g/L; Total bilirubin ≤1.5 × ULN; AST and ALT ≤2.5 × ULN; Creatinine clearance ≥50 mL/min; TSH within normal limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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