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Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment, A Phase II Study

RecruitingPhase 2Ages 18 Years - 75 YearsAllRenmin Hospital of Wuhan University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients with histologically or cytologically and radiologically confirmed advanced metastatic or recurrent colorectal cancer; 2. Aged between 18-75 years; 3. ECOG status of 0-1; 4. At least one measurable lesion (RECIST v1.1); 5. Failure of at least second-line standard treatment 6. No history of treatment with JAK1 inhibitors; 7. Voluntarily sign the informed consent form. Exclusion Criteria: 1. History of previous treatment with a JAK1 inhibitor; 2. History of active autoimmune disease or primary immunodiciency within the past 2 years; 3. Allergic to monoclonal antibodies or food additive carboxymethylcellulose sodium and its components; 4 Major cardiovascular and cerebrovascular diseases: such as cerebrovascular accident or myocardial infarction within 6 months before enrollment, uncontrolled hypertension, unstablegina, heart failure (NYHA grade II-IV), severe arrhythmia requiring drug treatment, etc.; 5\. Suffered from other malignant tumors within5 years before enrollment (excluding excised basal cell carcinoma of the skin and cervical carcinoma in situ); 6. Vulnerable groups: including patients with mental, cognitive impairment, critical patients, minors, pregnant or lactating women, illiterate, etc.; 7. Severe chronic obstructive pulmonary disease (COPD, interstitial lung disease, or other diseases that severely affect pulmonary function; 8. Severe hepatic insufficiency, ALT and AST โ‰ฅ 25 ร— ULN (without liver metastasis), ALT and AST โ‰ฅ 5.0 ร— ULN (patients with liver metastasis); 9. Se renal insufficiency (CrCl \< 30 or 60 mL/min); 10. Previous anticancer treatment-induced toxicities not recovered โ‰ค grade 1 (excluding alopecia); 11. Patients with venous thrombosis; 12. Active tuberculosis,gal and/or viral infection.
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What it tests

  • Ivarmacitinib + Camrelizumab + Fruquintinib
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Where

1 site
Renmin Hospital of Wuhan University
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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