OncoMatch/Clinical Trials/NCT07448142
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
Official title: A Randomized, Two-Arm, Open-Label Phase II Trial of Low-Dose Radiotherapy Sensitization Combined With Pucotenlimab and CAPEOX as Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Adenocarcinoma
Is NCT07448142 recruiting? Yes, currently enrolling (Oct 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. Tumor response will be assessed after two cycles using endoscopy and pelvic magnetic resonance imaging (MRI). Participants with non-progressive disease, defined as partial response (PR) or stable disease (SD), will receive no further low-dose radiotherapy and will continue pucotenlimab plus CAPEOX for cycles 3 and 4. Participants with local progressive disease, defined as enlargement of the rectal tumor, will receive salvage chemoradiotherapy according to the center's standard operating procedures. Participants who develop distant metastases will receive further treatment determined by a multidisciplinary team (MDT). After four cycles, participants who achieve a clinical complete response (cCR) may enter a watch-and-wait strategy. Participants without cCR and without progressive disease will undergo radical surgery according to total mesorectal excision (TME) principles. Participants with progressive disease will receive individualized treatment determined by the MDT.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Disease stage
Required: Stage T2N+
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
Cannot have received: systemic anticancer therapy for rectal cancer
Prior treatment with ... 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 × uln; ast and alt ≤2.5 × uln
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.
Are there prior therapy exclusions?
Yes. Prior pelvic or abdominal radiotherapy, immune checkpoint inhibitor, systemic anticancer therapy for rectal cancer disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
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