Recruiting nowPhase 2
What this trial is trying to do
The researchers think blocking JAK1, a protein involved in immune-suppressing JAK/STAT signals, may make otherwise “cold” tumours more accessible to immune attack. They are testing whether ivarmacitinib combined with the PD-1 inhibitor camrelizumab and the cancer-growth inhibitor fruquintinib can control metastatic colorectal cancer after several previous treatments.
Treatment options are limited after two or more lines of therapy, especially when immunotherapy alone is unlikely to activate enough T cells. The trial asks whether this three-drug combination can delay further cancer growth, measured mainly by progression-free survival (PFS), while also assessing tumour responses and safety.
Worth knowing: This is a small, single-centre, single-arm exploratory trial with no comparison group, and PFS is not the same as living longer.
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 | NCT07896096 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 33 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Renmin Hospital of Wuhan University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Ivarmacitinib Sulfate Tablets
- Drug Camrelizumab
- Drug Fruquintinib
What it is measuring
PFS
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
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells.
To address this challenge, the investigators propose an innovative combination strategy aimed at remodeling the TME and alleviating immunosuppression. The investigators hypothesize that ivarmacitinib, a highly selective JAK1 inhibitor, may attenuate the immunosuppressive TME through modulation of JAK/STAT signaling, potentially converting "cold" tumors into "hot" tumors and enhancing the antitumor activity of camrelizumab, a PD-1 inhibitor, in combination with fruquintinib, a tyrosine kinase inhibitor (TKI).
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
- Histologically or cytologically confirmed advanced, metastatic, or recurrent colorectal cancer, supported by radiological findings.
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Disease progression or failure of at least second-line standard therapy.
- Voluntary provision of written informed consent.
Exclusion Criteria
- Prior treatment with a JAK1 inhibitor.
- Active autoimmune disease or primary immunodeficiency within the previous 2 years.
- Known allergy to monoclonal antibodies, sodium carboxymethylcellulose, or any of their components.
- Major cardiovascular or cerebrovascular diseases, including stroke or myocardial infarction within 6 months before enrollment, uncontrolled hypertension, unstable angina, heart failure (New York Heart Association [NYHA] class II-IV), or severe arrhythmias requiring pharmacological treatment.
- History of other malignancies within 5 years before enrollment, except for excised basal cell carcinoma of the skin or cervical carcinoma in situ.
- Membership in vulnerable populations, including individuals with mental or cognitive impairment, critically ill patients, minors, pregnant or breastfeeding women.
- Severe chronic obstructive pulmonary disease (COPD), int…
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 NCT07896096, registered by Renmin Hospital of Wuhan 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.