Colorectal cancer
Conditions
Interventions
Intervention group:fuquinitinib plus TAS-102
Observation group:beacizumab bead sheet resistance to chemotherapy (with induction therapy)
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, no gender restriction; 2. Patients with histologically or cytologically confirmed unresectable metastatic colorectal adenocarcinoma and RAS mutation confirmed by genetic testing; 3. Patients who failed first-line treatment with bevacizumab combined with oxaliplatin-based chemotherapy, then received second-line induction therapy with bevacizumab combined with the FOLFIRI regimen for 8 cycles and achieved disease control (CR, PR, or SD) as assessed by RECIST 1.1 imaging. (Previous bevacizumab combined with oxaliplatin-based chemotherapy as adjuvant or neoadjuvant therapy is allowed, but if recurrence or metastasis occurs within 6 months after completion of adjuvant/neoadjuvant therapy, this treatment is considered a first-line systemic therapy); 4. ECOG performance status score of 0 or 1; 5. Time since last chemotherapy =12 weeks; 8. Adequate organ function: (1) Hematologic: Absolute neutrophil count (ANC) =1.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=90 g/L (without transfusion within 14 days); (2) Liver function: Total bilirubin (TBIL) =50 ml/min (calculated using the Cockcroft-Gault formula); (4) Coagulation: International normalized ratio (INR) <=1.5, activated partial thromboplastin time (APTT) <=1.5×ULN (without anticoagulant therapy); 9. Ability to understand and sign the informed consent form, voluntarily participate in this study, and comply with the study protocol to complete follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any VEGF-TKI (such as regorafenib, apatinib, fruquintinib, etc.); 2. Colorectal cancer identified as MSI-H by genetic testing or dMMR by immunohistochemistry; 3. Symptomatic central nervous system (CNS) metastases (unless asymptomatic, stable for at least 4 weeks, and not requiring corticosteroid treatment); 4. Uncontrolled severe cardiovascular disease, such as: (1) NYHA class 2 or above; (2) Myocardial infarction, severe or unstable angina, stroke, or transient ischemic attack (TIA) within the past 6 months; (3) Uncontrolled hypertension (systolic >=140 mmHg and/or diastolic >=100 mmHg despite optimal medication). History of hypertensive crisis or hypertensive encephalopathy; 5. Unhealed wounds, ulcers, or fractures, or plans for major surgery during the study period; 6. Severe, uncontrolled infections (e.g., requiring intravenous anti-infective treatment); 7. Active gastrointestinal bleeding or high risk of perforation (e.g., history of bowel obstruction, extensive adhesions, etc.); 8. Urine protein >=2+ (urinalysis) or 24-hour urine protein >=1 g; 9. Known allergy to the investigational drug or any of its excipients, or difficulty swallowing; 10. Receiving other anti-tumor therapies (including experimental drugs); 11. Pregnant or breastfeeding women, or patients of reproductive age unwilling to use effective contraception during the study and for 6 months after the last dose; 12. Presence of mental illness or cognitive disorder preventing compliance with the study. Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactYifu He
Anhui Provincial Cancer Hospital
Outcome results
None listed