Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether giving dupilumab, which blocks signalling from the immune-related proteins IL-4 and IL-13, together with toripalimab, a PD-1 immune-checkpoint inhibitor, before surgery can make microsatellite-stable (MSS) colorectal cancer liver metastases more vulnerable to the immune system. The treatment is given before planned removal of the metastases.
The hope is that preoperative immunotherapy will produce a major pathological response—little or no living cancer found in the removed tissue—more often than expected with usual treatment, while remaining safe enough to reach surgery. The trial measures this tissue response in Phase 2, and dose-limiting toxicities in the early safety phase; it does not directly test longer survival.
Worth knowing: This is a small, non-randomised early-phase trial with no comparison group, so any pathological responses cannot yet be separated from the effects of other treatment or linked to improved 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 | NCT07277322 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 24 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Dan Feng |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Dupilumab
- Drug Toripalimab
What it is measuring
Number of dose limiting toxicities (DLTs)
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 Phase 1b/2 study of neoadjuvant dupilumab and toripalimab in MSS CRC subjects with resectable liver metastases. The primary objective of Phase 1b is to determine the safety of neoadjuvant immunotherapy in MSS CRC subjects with resectable liver metastases. The primary objective of Phase 2 is to determine the efficacy of immunotherapy in MSS CRC subjects with resectable liver metastases as measured by the percentage of subjects achieving a major pathological response (MPR). Eligible subjects will receive dupilumab (600mg on Day 1 and 300mg on D15 ±2 days) and toripalimab 240mg on Day 1 before planned surgery. Dupilumab is administered as a subcutaneous injection. Toripalimab is administered intravenously over 60 minutes or longer. Based on clinical signal in the current cohort and new findings in animal models, additional cohorts will be added to test different immunotherapy combinations in the same patient population with the same endpoints and statistical method in the future.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- 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
Histological diagnosis of non-MSI-H/pMMR CRC
- Subjects who have biology-proven non-MSI-H/pMMR CRC and with radiographic findings suggestive of liver metastases may be eligible.
Resectable liver metastases including
- synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve
- metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy
- metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.
Surgical candidate for resection
Age ≥ 18 years. Rationale: Because no dosing or adverse event data are currently available on the use of dupilumab in combination with toripalimab in subjects <18 years of age, children are excluded from this study.
ECOG Performance Status 0-1 (Karnofsky ≥60%,)
- Subjects with performance status >1 carrying long-term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy may be enrolled at the investigator's discretion
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy.
- A female of…
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: United States.
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 NCT07277322, registered by Dan Feng 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.