Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether radiotherapy combined with tislelizumab, liposomal irinotecan and capecitabine can shrink high-risk, locally advanced low or mid-rectal cancer before surgery. Tislelizumab is an immune-checkpoint inhibitor intended to help immune cells attack cancer, while irinotecan and capecitabine are chemotherapy drugs that damage cancer cells.
The idea is that this combination could produce more complete responses before surgery, potentially making local treatment easier, while the trial also measures safety. The main outcome is the rate of complete responses, not how long people live or how long it takes the cancer to grow.
Worth knowing: This is a small, non-randomised phase 2 trial with no comparison group, and it is limited to people with pMMR (the usual mismatch-repair status) high-risk, non-metastatic rectal cancer.
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 | NCT07104604 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 51 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Affiliated Cancer Hospital of Shantou University Medical College |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy
What it is measuring
Complete response (CR) 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.
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
The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.
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
Here is the updated format for the **Eligibility Criteria** with bullet points for each item:
Inclusion Criteria
- Age: 18-75 years, no gender restriction
- ECOG score 0-1
- Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)
- Presence of the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to undergo sphincter-preserving surgery
- Routine chest and abdominal CT scans showing no distant metastasis
- Bone marrow function: Neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 70 g/L
- Liver function: ALT, AST ≤ 2.5 × ULN (upper limit of normal); total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g/dL
- Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula)
- For females and patients with reproductive potential, a negative pregnancy test must be done within 72 hours before starting the treatment, and the patient must agree to avoid pregnancy during the study treatment and for 6 months after the treatment.
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 2 sites. 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 NCT07104604, registered by Affiliated Cancer Hospital of Shantou University Medical College 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.