Metastatic colorectal cancer
Conditions
Interventions
Experimental group:Irinotecan liposome 60 mg/m^2, intravenous infusion over 90 minutes (±30 minutes) on Day 1, every 3 weeks (Q3W)
Capecitabine 800 mg/m^2 per dose, orally, twice daily, Days 1–14, every 3 weeks (Q3W)
Bevacizumab 7.5 mg/kg, intravenous infusion on Day 1, every 3 weeks (Q3W)
If the patient has a homozygous UGT1A1*28 allele, the dose of irinotecan liposome should be adjusted to 50 mg/m^2
Sponsors
Tianjin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed unresectable colorectal adenocarcinoma, excluding goblet cell carcinoid of the appendix and anal canal cancer; 2. Male or female, aged >=18 and =12 weeks; 7. Normal major organ and bone marrow function, meeting the following requirements: (1) Hematologic function: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 75 x 10^9/L; (2) Adequate renal function: serum creatinine 40 mL/min (Cockcroft-Gault formula); (3) Hepatic function: total bilirubin =50%; QTc <450ms for males, <470ms for females; 8. Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and use effective contraception during the study and for at least 3 months after the last dose (e.g., IUD, contraceptive pills, or condoms); male participants with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose; 9. Participants voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Has received irinotecan treatment before; 2. Has clinical symptoms that cannot be controlled by drainage or other methods and involve third-space effusion (such as large amounts of pleural effusion or ascites); 3. Has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (including hormone replacement therapy), and vitiligo); has completely resolved childhood asthma and no intervention is needed after adulthood or vitiligo can be included; patients requiring bronchodilators for medical intervention are not included; 4. Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method) or co-infection of hepatitis B and hepatitis C; 5. Had severe infection within 2 weeks before the first medication (such as: requiring intravenous infusion of antibiotics, antifungal or antiviral drugs); 6. Had thromboembolic events in the arteries or veins within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 7. Had other systemic malignant tumors within the last 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer; 8. Has known allergies to any trial drugs; 9. Pregnant or lactating patients, patients with reproductive ability who are unwilling to take effective contraceptive measures; 10. Has a clear history of neurological or mental disorders, including epilepsy and dementia; 11. Has uncontrollable or symptomatic active central nervous system (CNS) metastasis, manifested as clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease and/or progressive growth; 12. Patients unable to swallow the study drug, such as those with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction that affect the administration and absorption of the drug; 13. Other conditions that the investigator considers not suitable for inclusion, such as those affected by family or social factors that may endanger the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Time to Treatment Failure, TTF;Objective response rate, ORR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactXu Jing
Tianjin People's Hospital
Outcome results
None listed