Metastatic colorectal cancer
Conditions
Interventions
"Ivarmacitinib, Camrelizumab, and Fruquintinib" Combination Therapy Group:Participants receive ivarmacitinib monotherapy for 2 weeks, followed by a 3-week induction phase with ivarmacitinib, camrelizu
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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 = 25 × ULN (without liver metastasis), ALT and AST = 5.0 × ULN (patients with liver metastasis); 9. Se renal insufficiency (CrCl < 30 or 60 mL/min); 10. Previous anticancer treatment-induced toxicities not recovered = grade 1 (excluding alopecia); 11. Patients with venous thrombosis; 12. Active tuberculosis,gal and/or viral infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Adverse events and serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactDandan Lin
Renmin Hospital of Wuhan University
Outcome results
None listed