NCT07896096RecruitingPhase 2
Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
A Phase II Study of Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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). Accordingly, a single-arm, single-center, exploratory phase II clinical study was designed to enroll 33 patients with mCRC who have failed multiple lines of prior therapy. The study aims to evaluate the ORR, survival outcomes, and safety of this combination regimen. The findings are expected to provide preliminary evidence for a potential new therapeutic approach for this heavily pretreated patient population and establish a foundation for subsequent larger confirmatory studies.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 14 Apr 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Renmin Hospital of Wuhan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07896096
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 14 Apr 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a JAK1 inhibitor.
- Active autoimmune disease or primary immunodeficiency within the previous 2 years.
- 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.
- Toxicities from previous anticancer treatment that have not recovered to Grade 1 or lower, except for alopecia.
Other illness
- 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.
- History of venous thrombosis.
- Active tuberculosis or active bacterial, fungal, or viral infection.
Lab values
- Known allergy to monoclonal antibodies, sodium carboxymethylcellulose, or any of their components.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.