Metastatic colorectal cancer
Conditions
Interventions
Experimental group:Inanoliposomal irinotecan +Targeted drug
Sponsors
Yijishan Hospital, Wannan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Understand and be willing to sign written informed consent and be able to follow research protocols for treatment; 2.Age >=18 years old ; 3.Histologically or cytologically confirmed colorectal cancer; 4.According to the RECIST v1.1 criteria, there is measurable metastasis and radical surgery is not appropriate; 5.First-line treatment with fluorouracil and oxaliplatin is intolerant or fails; 6.ECOG performance status of 0-2; 7.Predicted survival time >= 3 months. 8.Adequate organ function,The definition is as follows: (Hematology and blood biochemistry examination should be completed within 14 days prior to enrollment, and the following conditions should be met) a. Absolute neutrophil count (ANC) >=1.5*109/L b. Hemoglobin >=90g/dL c. Platelets (PLT) >=100*109/L d. Total bilirubin =50mL/min (urine collected for 24 hours or calculated using the Cockroft-Gault method). 9.Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1.Active infection: such as HIV infection, chronic HBV/HCV in the active phase; 2.The presence of serious concomitant diseases: clinically severe heart disease, renal failure, liver failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, etc; 3.Severe diarrhea; 4.Severe mental illness; 5.The investigators evaluated patients who were not eligible to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;Safty; | — |
Countries
China
Contacts
Public ContactSheng Lili
Yijishan Hospital, Wannan Medical College
Outcome results
None listed