Recruiting nowPhase 1
What this trial is trying to do
The researchers think low-dose radiotherapy (LDRT) may alter the tumour immune microenvironment—the immune cells and signals around the cancer—so that tislelizumab, an immunotherapy, works more effectively alongside XELOX chemotherapy. This early trial is testing whether giving LDRT with short-course radiotherapy and immunochemotherapy is safe and feasible for colorectal cancer that has spread to the liver.
The idea is that combining radiation with immune treatment could produce more anti-tumour immune activity than treatment with chemotherapy and immunotherapy alone, but this trial is measuring treatment-related side effects and feasibility, not whether people live longer or go longer before the cancer grows.
Worth knowing: Only 9–18 people will be treated at one hospital, with no comparison group, so the trial cannot establish whether the combination improves cancer control.
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 | NCT06848465 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 9 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Low Dose Radiotherapy
- Radiotherapy Short course Radiotherapy
- Drug XELOX
- Drug Tislelizumab
What it is measuring
Incidence of treatment-emergent adverse events
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 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
- Colon
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 between18 and 75 years old.
2. Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
3. The clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound was T3-4Nx or TXN1-2.
4. Simultaneous liver metastasis confirmed by imaging examination.
5. No previous antitumor treatment.
6. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
7. Adequate cardiac function (Left Ventricular Ejection Fractions > 50%), hepatic function (total serum bilirubin ≤ 1.5 × upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate > 60 ml/min, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 109 cells per L).
8. Sign the informed consent and have good compliance.
Exclusion Criteria
1. Distant metastasis from other than the liver.
2. BMI < 18.5 kg/m² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on body weight).
3.
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 NCT06848465, registered by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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.