Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether CAPOX chemotherapy (oxaliplatin plus capecitabine) and the PD-1 inhibitor serplulimab work better when given before rather than after short-course radiotherapy in locally advanced rectal cancer. Serplulimab is intended to release a brake on immune cells so they can attack tumour cells, while CAPOX damages dividing cancer cells.
The comparison is about treatment sequence: the trial asks whether one order produces more complete responses, meaning no tumour is found at surgery or no tumour can be detected clinically. It also measures safety, surgical outcomes, recurrence and survival, but the main measure is the complete-response rate rather than how long people live.
Worth knowing: This phase 2 trial has 100 participants, and its main endpoint is a response measure that may not predict longer survival; the study is also testing two treatment sequences rather than a new treatment against standard care.
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 | NCT07898865 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years to 70 Years |
| Run by | Chongqing University Cancer Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy radiotherapy
- Drug CAPOX (oxaliplatin/capecitabine)
- Drug Serplulimab
What it is measuring
Complete Response (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, randomized, multicenter phase II trial evaluating neoadjuvant CAPOX chemotherapy combined with the PD-1 inhibitor serplulimab administered either before or after short-course radiotherapy (SCRT) in patients with locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, defined as pathological complete response (pCR) plus clinical complete response (cCR). Secondary endpoints include safety, perioperative outcomes, survival, recurrence patterns, and integrated multi-omics analyses of paired tumor samples. The study aims to determine the optimal sequencing strategy and identify immune microenvironmental biomarkers predictive of response.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Rectal
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
- Age 18-70 years, any sex.
- Clinical stage II/III rectal adenocarcinoma (cT3-T4N0 or cT2-T4N+, M0) according to AJCC 8th edition.
- Tumor located ≤10 cm from anal verge (confirmed by colonoscopy or digital rectal exam).
- Histologically confirmed rectal adenocarcinoma.
- ECOG performance status 0-1.
- Adequate organ function:
- Hemoglobin ≥90 g/L; WBC ≥3.5×10⁹/L; ANC ≥1.5×10⁹/L; Platelets ≥100×10⁹/L.
- Serum creatinine, BUN ≤1.0×ULN.
- ALT, AST, ALP ≤1.5×ULN; Total bilirubin ≤1.5×ULN.
- Negative urine protein; normal coagulation.
- No known allergy to fluoropyrimidines or platinum.
- No prior surgery (except diverting colostomy), chemotherapy, or radiotherapy for primary rectal cancer.
- No prior pelvic radiotherapy.
- Signed written informed consent.
Exclusion Criteria
- Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors, or other investigational immunotherapies.
- Active autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, scleroderma, SLE, vasculitis).
- Symptomatic interstitial lung disease or active pneumonia.
- GI conditions increasing risk of perforation (e.g., active diverticulitis, abscess, obstruction).
- History of other malignancies, except cured non-melanoma skin cancer or in situ cervical cancer.
- Active infections, uncontrolled heart failure, recent myocardial infarction (<6…
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 NCT07898865, registered by Chongqing University Cancer Hospital 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.