Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether adding bevacizumab, which blocks blood-vessel growth, and sintilimab, a PD-1 immune checkpoint inhibitor, to cetuximab plus irinotecan can make treatment work better in RAS-wild-type metastatic colorectal cancer after earlier treatments have stopped working. The idea is that bevacizumab may change the tumour environment so that sintilimab can help the immune system attack the cancer, even though PD-1 drugs alone usually have limited activity in microsatellite-stable disease.
Compared with cetuximab and irinotecan alone, the trial asks whether the four-drug combination produces a higher objective response rate—the proportion of patients whose tumours shrink by a predefined amount. The researchers' target is an increase from about 11% to 26%, but this outcome does not by itself show that people live longer or have more time before the cancer grows.
Worth knowing: This is an open-label phase 2 trial, and its main endpoint is tumour response rather than survival; the added drugs may also bring additional side effects.
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 | NCT07722754 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 160 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Guangdong Provincial People's Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Cetuximab
- Drug Irinotecan
- Drug Bevacizumab
- Drug Sintilimab
What it is measuring
Objective Response 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 randomized, multi-center, open-label phase II trial studies the efficacy and safety of irinotecan and cetuximab with or without bevacizumab plus sintilimab in the treatment for RAS wild-type metastatic colorectal cancer (mCR) in third- or later-line setting.
Patients with refractory mCRC have limited treatment options after failure of standard chemotherapies and anti-angiogenic agents. The BOND-3 trial showed that adding bevacizumab to cetuximab and irinotecan may improve outcomes in this setting. Meanwhile, programmed death-1 (PD-1) inhibitors have demonstrated activity in MSI-high tumors but have limited efficacy in MSS mCRC. Preclinical and clinical evidence suggests that anti-VEGF therapy can modulate the tumor immune microenvironment and may synergize with PD-1 blockade. This study therefore tests whether the quadruple combination (bevacizumab + sintilimab + cetuximab + irinotecan) can improve objective response rate compared with cetuximab and irinotecan alone in this heavily pretreated population.
The primary efficacy analysis will be conducted on the intention-to-treat population. Assuming an ORR of 11% in the control arm and 26% in the experimental arm, with a one-sided alpha of 0.05 and power of 80%, the required sample size is approximately 160 to account for 5% dropout.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- 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
- Metastatic and unresectable colorectal adenocarcinom;
- RAS wild-type and MSS tumor;
- Measurable lesions;
- Failed to at least two lines of standard treatment containing fluoropyrimidine, irinotecan and bevacizumab;
- Eastern Cooperative Oncology Group performance status 2 or less;
- White blood cell≥ 3*10^9/L, neutrophil≥ 1.5*10^9/Lplatelet count≥75*10^9/L, hemoglobin≥60g/L;
- Total serum bilirubin≤upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5*ULN or ≤5*ULN for subjects with liver metastasis;
- Creatinine ≤ ULN or creatinine clearance ≥ 80 mL/min;
- Urinary protein negative or 24-hour urinary protein ≤ 2g;
- Activated partial thromboplastin time≤ULN and international normalized ratio≤1.5;
- Any major surgery ≥ 4 weeks and any minor surgery ≥ 1 week and fully recovered from the procedure;
- Life expectancy > 3 months;
- Provide fully informed written consent;
Exclusion Criteria
- Other aggressive malignancies within 3 years (Exceptions: non-melanoma skin cancer or carcinoma-in-situ of the cervix that has been treated);
- Allergy or intolerance to any of the study drugs;
- Human immunodeficiency virus positive;
- Concurrent anti-cancer therapy including radiation therapy, chemotherapy, targeted agents or biological agents not otherwise specified within two weeks;
- Malignant bowel…
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 NCT07722754, registered by Guangdong Provincial People's Hospital 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.