Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced R… (NCT07528209) | Clinical Trial Compass
RecruitingPhase 3
Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer
China556 participantsStarted 2026-04-20
Plain-language summary
This is a multicenter, phase III, randomized controlled trial. Eligible patients with pMMR/MSS locally advanced rectal cancer will be randomized in a 1:1 ratio to either the experimental group or the control group using stratified randomization, with mesorectal fascia (MRF) status as the stratification factor.
Patients in the experimental group will receive four cycles of CAPOX plus pucotenlimab. Patients in the control group will receive four cycles of CAPOX alone.
Tumor response will then be assessed. Patients with tumor shrinkage ≥20% and no persistent tumor involvement of the mesorectal fascia will proceed directly to surgery. Patients with tumor shrinkage \<20% or persistent MRF-positive disease will receive short-course radiotherapy, followed by two additional cycles of CAPOX plus pucotenlimab in the experimental group or CAPOX alone in the control group. After completion of neoadjuvant treatment, efficacy will be reassessed, and the timing of surgery will be determined according to treatment response. Postoperative adjuvant therapy will be decided by the investigator.
Who can participate
Age range18 Years – 75 Years
SexALL
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✓. The lower edge of the tumor is ≤12 cm from the anal verge.
✓. Clinical stage of cT3-4aN0M0 or cT1-4aN+M0 at initial diagnosis.
✓. pMMR status confirmed by immunohistochemistry on colonoscopic biopsy specimens at the pathology department of the study center, or MSS/MSI-L status confirmed by genetic testing (PCR-based or NGS-based methods).
✓. ECOG performance status 0-1.
✓. Voluntary participation in the study with written informed consent provided.
✓. No prior antitumor treatment for rectal adenocarcinoma, including but not limited to radiotherapy, chemotherapy, or surgery.
✕. a short-axis diameter \<7 mm with at least two malignant imaging features, such as heterogeneous signal intensity, irregular shape, or spiculated margins.
✕. Predicted inability to preserve the anus. This is defined as tumor involvement of the dentate line and assessment by two senior colorectal surgeons that sphincter preservation is not feasible.
✕. Active autoimmune disease requiring systemic treatment within 2 years before enrollment, including but not limited to myasthenia gravis, systemic lupus erythematosus, interstitial pneumonitis, uveitis, ulcerative colitis, autoimmune hepatitis, hypophysitis, systemic vasculitis, nephritis, hyperthyroidism, hypothyroidism, or mixed connective tissue disease.
✕. Use of systemic corticosteroids within 14 days before the first dose of study treatment at a dose ≥10 mg/day prednisone equivalent, or use of other immunosuppressive agents, including but not limited to cyclosporine, cyclophosphamide, azathioprine, methotrexate, or thalidomide.
✕. Receipt of a live vaccine or attenuated live vaccine within 30 days before the first dose, or planned vaccination with such vaccines during the study period.