Advanced Colorectal Cancer
Conditions
Interventions
Intervention group:Drug therapy: liposomal irinotecan combined with carbidopa
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed colorectal adenocarcinoma 2. Patients with advanced colorectal cancer who have not received any systemic anti-tumor therapy for metastatic lesions and have not received any prior systemic anti-tumor therapy for metastatic lesions; 3. Age>=18 years old, male or female; 4. Must have at least one measurable lesion as the target lesion (according to RECISTv1.1 criteria); 5. ECOG:0~1; 6. Expected survival >=3 months; 7. Oral medication can be accepted; 8. Normal function of major organs, meeting the following criteria within 14 days prior to the start of treatment: 1 neutrophil count>=1.5×10*9/L; 2 Platelet count>=75×10*9/L; 3 Hemoglobin >=9.0g/dL; 4 AST60mL/min or serum creatinine <=1.5 ×UNL 9. Women of childbearing potential must have had a blood pregnancy test within 3 days prior to randomization with a negative result and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after the end of treatment. For males, should be surgically sterile, or agree to use an appropriate method of contraception for the duration of the study and for 3 months after the end of treatment; 10. Subjects voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced cancer of MSI-H or dMMR; 2. Patients with wild-type advanced bowel cancer with RAS/NRASF gene in the left half; 3. UGT1A1*6, UGT1A1*28 gene phenotype is unit point mutation (GG+6/7 or GA+6/6), two-site mutant (GG+7/7 or AA+6/6 or GA+6/7), Patients with three-digit point mutations (AA+7/7 or AA+6/7 or GA+7/7); 4. Those with a history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ 5. Those with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, by the investigator Judging its clinical severity may preclude the signing of the informed consent form or affect the patient's oral medication Compliance with things 6. Clinically serious (i.e., active) heart disease, such as symptomatic coronary heart disease, New York heart disease Organ Disease Association (NYHA) Class II or greater congestive heart failure or severe need Cardiac arrhythmia with pharmacological intervention (see Appendix 12), or myocardium within the last 12 months History of infarction 7. Those who need immunosuppressive therapy for organ transplantation 8. Severe uncontrolled recurrent infection, or other serious uncontrolled concomitant diseases 9. The subject's baseline blood routine and biochemical indexes do not meet the following criteria: Platelet >= 90g/L; Absolute neutrophil count (ANC) >=1.5×10?/L; Platelets > = 100×10?/L; ALT, AST = 30 g/L 10. Known dihydropyrimidine dehydrogenase (DPD) deficiency 11. Those who are allergic to any of the study ingredients 12. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactLu Wangxia
Zhejiang Cancer Hospital
Outcome results
None listed