colorectal cancer
Conditions
Interventions
experimental group:Fruquintinib + cetuximab beta + epcoritamab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed advanced colorectal adenocarcinoma with measurable extraintestinal lesions (=10 mm on spiral CT, meeting RECIST 1.1 criteria); 2. Aged 18–75 years, regardless of gender; 3. ECOG performance status (ECOG/PS) score of 0–2; 4. Microsatellite stable (MSS) status confirmed by histological genetic testing; 5. Wild-type status of NRAS, KRAS, and BRAF confirmed by histological genetic testing; 6. Patients who have progressed after or are intolerant to second-line treatment; 7. Expected survival of =3 months; 8. Normal organ function meeting the requirements for targeted therapy: Normal bone marrow reserve: absolute neutrophil count (ANC) >=1.5×10?/L, platelet count (PLT) >=80×10?/L, hemoglobin (Hb) >=90 g/L; Normal renal function: serum creatinine (Cr) =60 mL/min;Normal liver function: total serum bilirubin (TBIL) <=1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5×ULN; if liver function abnormality is caused by underlying malignancy, AST/ALT <=5×ULN; 9. Voluntary participation in the study, signed informed consent form, good compliance, and willingness to cooperate with follow-up. 10. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and voluntarily use appropriate contraceptive methods during the study period and for 8 weeks after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with regorafenib, fruquintinib, or other small-molecule tyrosine kinase inhibitors (such as apatinib, anlotinib, etc.); 2. Patients who received cetuximab as second-line therapy, or patients with progression-free survival (PFS) II; (2) Active coronary artery disease; (3) Arrhythmia requiring treatment other than beta-blockers or digoxin; (4) Unstable angina (angina at rest), new-onset angina within 3 months before enrollment, or new-onset myocardial infarction within 6 months before enrollment; 8. Patients scheduled to receive radiotherapy; 9. Patients with depression, mania, obsessive-compulsive disorder, or schizophrenia; 10. Participation in another clinical trial of investigational drugs within the past 4 weeks; 11. Pregnant or lactating women; 12. Severe hypertension or uncontrolled hypertension; 13. Any patient considered ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;Disease control rate;Duration of Response;Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactChen Yongchang
Sichuan Cancer Hospital
Outcome results
None listed