Recruiting nowPhase 3Randomised
| Registry number | NCT06280495 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 156 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Oxaliplatin
- Drug Fluorouracil
- Drug Serplulimab
- Drug Bevacizumab
What it is measuring
3-year Progression-Free Survival 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.
What this trial is trying to do
The researchers think that adding serplulimab, a PD-1 inhibitor that removes one brake on immune-cell activity, and bevacizumab, which blocks tumour blood-vessel growth, to FOLFOX chemotherapy may make liver metastases more accessible to immune attack. The trial tests this combination before surgery against FOLFOX alone in people with operable colorectal cancer that has spread to the liver.
The comparison asks whether the combination improves the postoperative course, measured mainly by the proportion of patients alive without their cancer worsening three years later (3-year progression-free survival). The researchers also expect it could increase T-lymphocyte, or immune-cell, infiltration in the liver, but the trial does not establish that this will happen or improve survival.
Worth knowing: This applies only to surgically resectable liver metastases in tumours that are RAS/BRAF wild-type and pMMR/MSS, and its main endpoint is progression-free survival rather than overall 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.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
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
- Age ≥18 and ≤75 years old
- Histologically confirmed colorectal adenocarcinoma
- Radiological and/or pathological confirmation of liver metastases, with ≤5 lesions
- Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
- Absence of extrahepatic metastases confirmed by CT, MRI, or PET/CT (if necessary)
- Primary colorectal tumor has been or can be radically resected
- Liver metastatic lesions are resectable (including radiofrequency ablation and SBRT), and postoperative NED (no evidence of disease) is expected. Resectable liver metastases are specifically defined as ① ≤5 metastatic lesions; ② R0 resection can be performed (including radiofrequency ablation and SBRT); ③ Sufficient residual liver volume is expected after resection; ④ At least one hepatic vein can be preserved after resection, with preserved blood flow in and out of the residual liver and preserved bile ducts, and can preserve at least two adjacent liver segments; ⑤ No extrahepatic metastases.
- No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions
- Normal hematological function (platelets >90×109/L; white blood cells >3×109/L; neutrophils >1.5×109/L)
- Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 ULN, no ascites…
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 NCT06280495, registered by Sun Yat-sen 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.