Recruiting nowNot phased
What this trial is trying to do
The researchers are testing whether short-course radiation followed by six cycles of liposomal irinotecan, oxaliplatin and capecitabine, plus sintilimab, can eliminate high-risk locally advanced rectal cancer before surgery. Sintilimab blocks PD-1, an immune checkpoint that can restrain T cells, so the idea is that combining immune treatment with chemotherapy and radiation may increase tumour clearance.
The trial asks whether this pre-surgery sequence can produce a complete response often enough for some patients to enter close monitoring instead of having immediate surgery, while also measuring safety. Its main measure is complete response rate, so it is assessing tumour disappearance and the possibility of avoiding surgery—not yet whether people live longer.
Worth knowing: This is a small, single-centre, non-randomised exploratory study with no comparison group, and complete response is not the same as improved 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 | NCT07474103 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | open label |
| Taking part | 49 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy SCRT
- Drug Liposomal Irinotecan
- Drug Oxaliplatin
- Drug Capecitabine
- Drug Sintilimab
What it is measuring
Complete Response Rate
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.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy.
All participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles.
For patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program ("Watch and Wait") will be considered.
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
- Voluntary Participation: Subjects voluntarily participate in the study, sign the informed consent form, and have good compliance.
- Age and Gender: Age between 18 and 75 years, any gender.
- Pathological Diagnosis: Histologically or cytologically confirmed rectal adenocarcinoma; confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) by genetic testing or immunohistochemistry.
- Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal exam, or MRI. High-risk definition: Meeting at least one of the following: cT4, extramural vascular invasion (EMVI), tumor deposits, involvement of the mesorectal fascia or intersphincteric plane.
- Prior Treatment: No prior anti-tumor therapy for this rectal cancer (including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy).
- Measurable Lesion: At least one measurable lesion according to RECIST v1.1 criteria.
- Tumor Tissue Sample: Must provide tumor tissue samples for biomarker analysis.
- Adequate Organ Function (within 7 days before the first dose): 1) Hematological: Hemoglobin ≥90 g/L; White Blood Cell count ≥3.0 x 10⁹/L; Absolute Neutrophil Count ≥1.5 x 10⁹/L; Platelets ≥100 x 10⁹/L. 2) Hepatic: Total Bilirubin <1.5 x ULN; AST and ALT ≤2.5 x ULN; Albumin ≥30 g/L.
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 NCT07474103, registered by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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.