Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat
- •Potwierdzony histologicznie rak gruczołowy odbytnicy
- •Nowotwór w obrębie 10 cm od otworu odbytniczego
- •Zaawansowana choroba lokalnie (stadium T2N+ lub T3-T4a)
- •Prawidłowe geny naprawy DNA (pMMR/MSS)
- •Brak przerzutów na badaniach obrazowych
- •Dobry stan ogólny (ECOG 0-1)
- •Prawidłowe wyniki badań krwi i funkcji narządów
✗ Disqualifies
- •Nowotwór naciekający sąsiednie narządy (T4b)
- •Przerzuty poza miednią
- •Wcześniejsze promieniowanie okolicy miednicy lub brzucha
- •Wcześniejsza immunoterapia lub chemioterapia na raka odbytnicy
- •Aktywne choroby autoimmunologiczne wymagające leczenia
- •Stosowanie leków immunosupresyjnych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- October 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651
Guangzhou, China
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/16/2026.
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