Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether 8 weeks of encorafenib, a drug that blocks the BRAF V600E pathway, plus cetuximab, which blocks EGFR signals, and mFOLFOX6 chemotherapy can shrink or control locally advanced BRAF V600E-mutant colorectal cancer before surgery. The treatment is given before planned tumour removal, including in some patients with removable metastases.
The idea is that adding BRAF and EGFR blockade to standard chemotherapy could improve tumour control in this high-risk molecular group. The main measure is 18-month disease-free survival—how many people remain without detectable cancer or recurrence after treatment and surgery—along with tumour response, surgical safety, side effects and quality of life.
Worth knowing: This is a small, single-arm phase II trial with no comparison group, so it cannot by itself show whether the combination is better than standard treatment; disease-free survival is also not the same as 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.
| Registry number | NCT07789210 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 25 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Zhejiang University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6
What it is measuring
18-month disease-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.
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
This is a single-arm, multicenter, phase II clinical trial evaluating the safety and efficacy of neoadjuvant encorafenib plus cetuximab N01 and mFOLFOX6 in patients with locally advanced BRAF V600E-mutated colorectal cancer, with or without resectable metastases. Eligible patients will receive 8 weeks of neoadjuvant treatment with encorafenib, cetuximab N01, and mFOLFOX6, followed by tumor response assessment and radical surgery when appropriate. The primary endpoint is 18-month disease-free survival (DFS). Secondary endpoints include perioperative safety, objective response rate, pathological response rate, 1-year DFS, 3-year DFS, overall safety, and quality of life. This study aims to explore whether incorporating BRAF and EGFR targeted therapy into standard chemotherapy in the neoadjuvant setting can improve tumor control and long-term outcomes in this high-risk molecular subgroup of colorectal cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- BRAF V600E
- Metastatic
- Locally advanced
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
- The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
- Age: 18-75 years old, PS score 0-1;
- Colorectal adenocarcinoma diagnosed by histopathology, preoperative staging: T4N0-2M0, T3N2M0, T0-4N0-2M1a (with metastatic lesions present, requiring MDT evaluation as resectable); PMMR/MSS, BRAF V600E mutation, and both NRAS and KRAS wild-type;
- Locally advanced colorectal cancer requires initial diagnosis of patients who have not received systematic treatment in the past. Patients with resectable metastatic lesions are required to have not received targeted therapy in the past, and new metastases after adjuvant therapy can be included in this study.
- The main organ functions well and meets the following criteria:
1. Blood routine examination criteria (corrected for no blood transfusion or use of hematopoietic stimulating factor drugs within 7 days before screening): hemoglobin (HGB) ≥ 90g/L (if chronic anemia is caused by chronic blood loss from the tumor and the researcher evaluates the stability of vital signs, it can be included in the group); absolute neutrophil count (NEUT) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 75 × 109/L;
2.
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 NCT07789210, registered by Zhejiang 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.