Colorectal cancer
Conditions
Interventions
Experimental group:Irinotecan liposomes, LV, and 5-FU should be given sequentially. irinotecan liposomal: 70 mg/m^2 intravenously for 90 minutes, day 1
LV 400 mg/m^2, intravenous infusion for 2 hours, day 1
5-FU 400mg/m^2, intravenous bolus, followed by 2,400 mg/m^2, intravenous pumping for 46~48 hours, the first day, repeated every 2 weeks, 3 cycles of treatment are expected.
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years old (including upper and lower limits); 2.Histologically confirmed unresectable or metastatic colorectal cancer, metastatic colorectal cancer that has failed second-line and above standard treatment; 3.Failed prior treatment with oxaliplatin and irinotecan; 4.At least 1 evaluable lesion at baseline according to RECIST 1.1 criteria; 5.Expected survival >= 3 months; 6.ECOG score 0 to 2; 7.No serious cardiac, pulmonary, hepatic, renal or other vital organ dysfunction; normal hepatic and renal function: AST, ALT = 30 mL/min; 8.Adequate bone marrow function: peripheral blood leukocytes>4.0×109/L, neutrophils>1.0×109/L, haemoglobin>90 g/L, platelets>100×109/L.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to monoclonal antibodies; hypersensitivity to irinotecan; 2.Severe intestinal complications as assessed by preliminary clinical or imaging studies: perforation, obstruction, uncontrolled bleeding; 3.Other serious medical conditions judged to impair the ability to tolerate study drug therapy and/or surgery; 4.Pre-existing or concurrent malignancies (including concurrent cancers) other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 5.Pregnant or breastfeeding women; 6.Patients with severe cardiovascular disease and diabetes that cannot be easily controlled; 7.Patients with mental disorders; 8.Patients with severe infections; 9.Patients receiving thrombolytic/anticoagulant therapy with bleeding qualities or coagulation disorders; or aneurysm, stroke, transient ischaemic attack, arteriovenous malformation; 10.Previous history of renal disease with urinary protein or clinically significant renal function abnormalities on urinalysis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective mitigation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| One-year overall survival (OS);PFS(Progression-Free Survival);DOR;DCR;Safety; | — |
Countries
China
Contacts
Public ContactGangling Tong
Peking University Shenzhen Hospital
Outcome results
None listed