Recruiting nowPhase 3Randomised
| Registry number | NCT06497985 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 430 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Chipscreen Biosciences, Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Tucidinostat
- Drug Sintilimab
- Drug Bevacizumab
- Drug Fruquintinib
What it is measuring
Overall Survival (OS)
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 are testing whether tucidinostat, a drug that alters gene-control enzymes, can make MSS/pMMR colorectal cancers more responsive to sintilimab, an immune checkpoint inhibitor, while bevacizumab blocks signals that help tumours grow blood vessels. This three-drug combination is being compared with fruquintinib alone.
The idea is that combining immune activation with blood-vessel blockade could control the cancer for longer than fruquintinib monotherapy. The main test is overall survival—whether people receiving the combination live longer—not simply whether scans show tumour shrinkage.
Worth knowing: This is an open-label trial restricted to MSS/pMMR colorectal cancers, a group in which checkpoint immunotherapy has generally been difficult to make effective.
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
A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS mutated
- Metastatic
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. Provide written informed consent for the study.
2. Age ≥18 years and ≤75 years.
3. Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
4. Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .
5. Have confirmed MSS or MSI-L, or pMMR.
6. KRAS status must have been previously determined (mutant or wild-type) .
7. Measurable disease per RECIST v1.1.
8. ECOG PS 0 or 1.
9. Adequate organ function.
10. Expected survival >12 weeks.
Exclusion Criteria
1. Prior use of HDAC inhibitor.
2. Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
3. Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
4. Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
5. Received radiotherapy within 28 days before the first dose of study treatment.
6.
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 NCT06497985, registered by Chipscreen Biosciences, Ltd. 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.