Colorectal cancer
Conditions
Interventions
Experimental group:Arterial perfusion, d1
Irinotecan liposomes, 70mg/m2, Q2W
Note: Hepatic artery perfusion (According to UGT1A1 gene test results to determine the dose, for UGT1A1*6 and UGT1A1*28 homozygous mutant population 50mg/m2, the subsequent treatment cycle, depending
5-FU 2400mg/m2, Q2W, 46h intravenous infusion
Bevacizumab 5mg/kg (assessed by investigators according to CRS score), Q2W, intravenous infusion
Sponsors
Lishui Central Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old; Histologically confirmed metastatic colorectal adenocarcinoma with potentially resectable/unresectable liver/lung metastases; (3) no previous treatment with irinotecan or irinotecan liposomes; (4) Consent to UGT1A1*28/*6 gene test; (5) At least one measurable or evaluable lesion according to RECIST v1.1; (6) ECOG score is 0~1; (7) Good bone marrow and organ function: ? Neutrophils (ANC) =1.5×109/L, platelets (PLT) =100×109/L, hemoglobin (Hb) =90g/L, white blood cells (WBC) =3.0×109/L, albumin (ALB) =32 g/L, and no bleeding tendency; ? AST, ALT and alkaline phosphatase (ALP) were all =2.5× upper limit of normal range (ULN), and =5×ULN when liver metastases occurred; Total bilirubin =1.5×ULN; Serum creatinine (Cr) =1.5×ULN or creatinine clearance =60 ml/min (calculated according to Cockroft-Gault); (8) Expected survival =3 months; (9) can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Previously received local treatment for metastatic lesions; (2) Patients allergic to the investigational drug and its excipients; (3) The previous treatment-related toxicity has not returned to NCI-CTCAE v5.0 class I or below (except hair loss); (4) Known or suspected central nervous system metastasis; (5) The use of potent depressants or inducers of CYP3A, CYP2C8, and UGT1A1 (anticonvulsants [phenytoin, phenobarbital, or carbamazepine], rifampicin, rifambutin, St.John's.) could not be discontinued or were not discontinued within 2 weeks prior to enrollment Wort], grapefruit juice, clarithromycin, itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, indinavir, etc.); (6) The presence of intestinal obstruction or the presence of symptoms and signs of intestinal obstruction; (7) There was a tendency of arterial embolism or severe bleeding (except bleeding caused by surgery) or existing embolism or severe bleeding within 6 months before enrollment, and anticoagulation therapy was required; (8) any serious or uncontrolled systemic disease, This includes uncontrolled hypertension (defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg after treatment with standardized antihypertensive drugs), heart disease, active bleeding, active viral infections (including hepatitis B, hepatitis C [if there is a positive hepatitis B surface antigen or core antibody, HBV DNA testing, HBV DNA testing, HBV DNA testing, and HBV DNA testing). Hepatitis B virus DNA more than 2×103 copies /mL should be excluded; if hepatitis C antibody positive, add HCV RNA, hepatitis C virus RNA more than 1×103 copies /mL should be excluded], human immunodeficiency virus [HIV] infection); (9) have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer; (10) Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures; (11) Patients considered unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical conversion rate;Duration of remission;Progression free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJi Jiansong
Lishui Central Hospital of Zhejiang Province
Outcome results
None listed