Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study explores a triple-drug regimen for adults with metastatic colorectal cancer that has not responded to at least two prior lines of therapy. The approach targets the tumor microenvironment to overcome resistance to immunotherapy in MSS/pMMR tumors. Participants receive ivarmacitinib sulfate tablets plus camrelizumab and fruquintinib, with eligibility requiring measurable disease, ECOG 0-1, and adequate organ function. The study is conducted at Renmin Hospital of Wuhan University in China. Primary goals focus on safety and efficacy signals to determine whether this combination can produce meaningful responses in this difficult-to-treat population.

Why it matters

Who can join: the full rules

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), interstitial lung disease, or other conditions that severely impair pulmonary function.
* Severe hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) in patients without liver metastases, or ≥ 5 × ULN in patients with liver metastases.
* Severe renal impairment, defined as creatinine clearance (CrCl) \< 30 mL/min.
* Toxicities from previous anticancer treatment that have not recovered to Grade 1 or lower, except for alopecia.
* History of venous thrombosis.
* Active tuberculosis or active bacterial, fungal, or viral infection.

Where it's running

• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Dr. Lin
• Email: 236772452@qq.com
• Phone: +86 177 6257 5104

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.