OncoMatch/Clinical Trials/NCT07448142
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
Is NCT07448142 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07448142 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 T2N+ 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.
Check if I qualifyRelated pages