Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether combining sintilimab, an immunotherapy that blocks the PD-1 immune checkpoint, with fruquintinib, a drug that inhibits blood-vessel growth, can control colorectal cancer that has spread to the liver. They are also testing whether adding focused or low-dose radiotherapy changes the treatment’s effects.
The idea is that the drug combination, with or without radiotherapy, might keep the cancer from growing for longer than later-line treatment would otherwise do. The main measure is progression-free survival, with overall survival and tumour response also assessed.
Worth knowing: This is a small, open-label phase 2 trial, and its main endpoint is time before progression rather than survival; the record does not describe a standard-treatment comparison.
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 | NCT06356584 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 62 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Shandong Cancer Hospital and Institute |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Immunotherapy (Sintilimab)
- Drug Targeted Therapy Agent (Fruquintinib)
- Radiotherapy Radiotherapy (SBRT and LDRT)
What it is measuring
Progression-free survival (PFS)
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
Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Already treated
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
- ECOG PS 0-2
- Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)
- MSS/pMMR subtype
- Previously received standard first- and second-line systemic anti-tumor therapy
- At least one measurable lesion as defined by RECIST 1.1 criteria
- Access to tumor samples for biomarker assessment
- Expected survival of ≥3 months
- Normal function of major organ systems (within 14 days before enrollment)
- No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.
- Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.
Exclusion Criteria
- Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.
- Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.
- Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for c…
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 NCT06356584, registered by Shandong Cancer Hospital and Institute 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.