Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether a single small dose of radiotherapy can make pMMR/MSS rectal cancer more responsive to pucotenlimab, a PD-1 immune-checkpoint antibody, together with CAPEOX chemotherapy before surgery. They are comparing 2 Gy with 5 Gy to see whether either dose produces better tumour responses while guiding later treatment according to early scans and endoscopy.
The idea is that stronger tumour shrinkage before surgery could increase complete clinical responses, allowing some people to use careful watch-and-wait rather than immediate radical surgery. The main measured outcome is complete response rate; recurrence, survival, quality of life and safety are also followed, but the trial does not yet show that this approach improves them.
Worth knowing: This is a small, open-label phase 2 trial comparing two radiotherapy doses rather than the treatment strategy with standard care, and its main endpoint is response rather than survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07448142 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 50 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Low-dose radiotherapy
- Drug Pucotenlimab
- Drug CAPEOX/XELOX
What it is measuring
Complete Response Rate (CR)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Written informed consent provided prior to any study-specific procedures.
- Age 18 to 75 years at the time of enrollment.
- Histologically confirmed rectal adenocarcinoma.
- Tumor located within 10 cm from the anal verge, as assessed by endoscopy or imaging.
- Locally advanced disease, defined as clinical stage T2N+ or T3-T4a (any N) based on pelvic magnetic resonance imaging (MRI).
- Proficient mismatch repair (pMMR) or microsatellite-stable (MSS) tumor status confirmed by immunohistochemistry or molecular testing.
- No evidence of distant metastasis on preoperative imaging, including chest, abdominal, and pelvic computed tomography (CT).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- 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 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Creatinine clearance ≥50 mL/min
- Thyroid-stimulating hormone (TSH) within normal limits
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a protocol-defined period after the last dose.
- Men with partners of childbearing potential must agree to use effective contraception during the st…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07448142, registered by Sun Yat-sen University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.