Ivarmacitinib, camrelizumab and fruquintinib for metastatic colorectal cancer after earlier treatments
Tests ivarmacitinib with camrelizumab and fruquintinib in hard-to-treat colorectal cancer.
Plain-language title generated from the registry record
Registry title: Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 with advanced or metastatic colorectal cancer that got worse or stopped responding after at least second-line standard treatment.
- Age
- 18 to 75 years
- Sex
- Women and men can both join.
- Disease stage
- Advanced, metastatic or recurrent colorectal cancer confirmed by tissue or cell tests and imaging, with at least one lesion that can be measured (RECIST 1.1). ECOG performance status 0-1.
- Earlier treatment
- The cancer must have progressed on, or failed, at least second-line standard therapy. Prior treatment with a JAK1 inhibitor is not allowed.
Main reasons for not taking part
- Active autoimmune disease or primary immunodeficiency within the previous 2 years
- Major heart or brain blood vessel disease, such as a stroke or heart attack within 6 months
- Another cancer within 5 years (a few exceptions apply)
- Pregnant or breastfeeding women
- Active tuberculosis or active bacterial, fungal or viral infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07896096, who can take part
Where in China
- Renmin Hospital of Wuhan UniversityWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Renmin Hospital of Wuhan University
- Trial code
- NCT07896096
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; 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.