Colorectal cancer liver metastasis
Conditions
Interventions
test group:DEB-TACE treatment regimen
Sponsors
Shandong First Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, gender is not limited; 2. Diagnosed as colorectal cancer liver metastasis by pathological histology/imaging or clinically (refer to the "Guidelines for Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis" 2023 Edition); 3. The liver is the only organ with distant metastasis; 4. At least one measurable liver metastasis lesion, and the tumor diameter is assessed to be > 1cm (mRECIST assessment); 5. The liver metastasis is initially determined to be unresectable by the MDT of the research center; 6. Liver metastases have not undergone interventional treatment (TACE, ablation, iodine particle therapy, etc.); 7. The tumor accounts for 3 months; 11. Child-Pugh liver function class A or B; 12. ECOG =2 points; 13. Adequate renal function (creatinine = 2.0mg/dl); 14. Women of childbearing age and men of childbearing potential voluntarily take appropriate contraceptive measures during treatment; 15. Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignancies, excluding adequately treated cervical carcinoma in situ or skin squamous cell carcinoma, or basically controlled skin basal cell carcinoma, except colorectal cancer; 2. Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; 3. Patients eligible for radical treatment (surgery or ablation); 4. Patients with any contraindications to irinotecan: chronic inflammatory bowel disease and/or intestinal obstruction; history of severe allergic reaction to irinotecan hydrochloride trihydrate, lactic acid or lactic acid and mannitol, or excipients in this product; severe bone marrow failure; history of Gilbert's syndrome (no specific examination required); 5. Patients with brain metastases or a history of uncontrolled mental illness or severe intellectual or cognitive impairment; 6. Patients with severe active infection requiring intravenous antibiotics during the screening period; 7. Patients with active hepatitis or severe infection that cannot be treated simultaneously; 8. Active bleeding or abnormal coagulation function (PT> 16s, APTT> 43s, INR> 1.5 x ULN), or bleeding tendency or receiving thrombolytic therapy; 9. Renal dysfunction: creatinine> 2 mg/dL or creatinine clearance 2 points, cachexia or multiple organ failure; 12. Unstable angina, angioplasty, stenting or myocardial infarction within 6 months; 13. Pregnant or lactating women, and those who are of fertility but refuse to take contraceptive measures; 14. Allergic to the trial drug; 15. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 16. Those who are considered unsuitable to participate in this trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transformation excision rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Actual R0 resection rate;Objective response rate;Progression Free Survival;recurrence-free survival;Time to intrahepatic progression;AE/SAE; | — |
Countries
China
Contacts
Public Contactjibing liu
Shandong First Medical University Cancer Hospital
Outcome results
None listed