Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether liposomal irinotecan, capecitabine chemotherapy and enlonstobart, an immune checkpoint inhibitor intended to help immune cells recognise cancer, can work with short-course radiotherapy before surgery for locally advanced rectal cancer. The liposomal formulation is a way of delivering irinotecan, while the treatment sequence is neoadjuvant therapy—treatment given before surgery.
The idea is that this combination might shrink or eliminate the tumour before surgery, increasing the chance of a complete response. The trial measures complete response and pathological complete response, meaning no cancer is found on examination or in the tissue removed at surgery; it does not directly measure longer survival or fewer side effects.
Worth knowing: This is a small, single-centre, single-arm Phase 2 trial with no comparison group, so any response cannot be separated from what might have happened with standard treatment.
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 | NCT07281157 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 30 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Tianjin Medical University Cancer Institute and Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy
What it is measuring
Complete response plus pathological complete response
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, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.
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
1. Age of 18-75 years old;
2. rectal adenocarcinoma confirmed by histology and/or cytology;
3. locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017);
4. Distance from lower margin to anal margin ≤ 10 cm;
5. Patients with at least one assessable lesion according to RECIST1.1 criteria;
6. ECOG 0-1;
7. the expected survival time was more than 12 months;
8. had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc.
9. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×10^9/L, white blood cell (WBC) ≥3.0×10^9/L;
10. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ≤5×ULN, total bilirubin <1.5 ULN;
11. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL/min (according to Cockcroft-Gault formula);
12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN;
13. exclude active or suspected infection;
14.
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 NCT07281157, registered by Tianjin Medical University Cancer Institute and 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.