Colorectal cancer liver metastasis
Conditions
Interventions
Group A:Callispheres microspheres were loaded with 100 mg irinotecan for the embolization, and surgical resection of metastases at different time points
Group B:Callispheres microspheres were loaded with 200 mg irinotecan for the embolization, and surgical resection of metastases at different time points
Group C:Callispheres microspheres were loaded with 400 mg irinotecan for the embolization, and surgical resection of metastases at different time points
Control group:After the examination is completed, the liver metastases are directly removed.
Sponsors
Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The primary tumor of colorectal cancer has undergone radical (R0) resection, patients who have not received chemotherapy after primary resection, or patients who have completed chemotherapy after liver metastases 12 months ago, intend to remove liver metastases ( Traditional second-stage resection mode; or, the primary colorectal cancer can be resected (R0), and the liver metastases should be removed first by using the "liver priority mode"; (2) The recurrence risk score (CRS score, AJCC/UICC 8th edition) is 3-5 points; (3) According to the anatomical basis of the liver and the extent of the lesion, the MDT team (including anorectal surgery, oncology, hepatobiliary surgery, imaging, interventional) experts can evaluate the liver metastases and R0 can be removed, and sufficient liver function can be retained (remaining Liver volume =30%-50%); (4) Age 18-80 years old; (5) The patient's general condition is allowed (ECOG score = 2 points), Karnofsky (KPS) functional status score = 70 points; there is no unresectable extrahepatic metastatic disease, or only pulmonary nodular lesions, but does not affect liver metastasis Focal resection decision; (6) Patients of childbearing age (male or female) have adequate contraceptive measures to exclude pregnant or lactating women; (7) There is no previous history of malignancy other than adequately treated in situ cervical cancer or non-melanoma skin cancer, unless there is a disease-free interval of at least 10 years; (8) The patient did not participate in any drug clinical trial within 30 days prior to enrollment; (9) Exclusion: peripheral neuropathy (CTC > grade 1), uncontrollable congestive heart failure, angina pectoris, hypertension or arrhythmia, history of neurological or psychiatric illness, active infection period; (10) Liver lesions are single- or double-leaf lesions suitable for interventional therapy, and the number of lesions does not exceed four; (11) Blood routine satisfaction: WBC = 3.0×10^9/L, platelets =100×10^9/L, neutrophil count > 1.5 x 10^9/l; (12) Adequate organ function reserve: serum creatinine = 2x normal upper limit (ULN), serum transaminase (AST and ALT) = 5 × ULN, total bilirubin = 1.5 x ULN, prothrombin time > 50% of normal value.
Exclusion criteria
Exclusion criteria: (1) There are contraindications to the use of irinotecan: chronic inflammatory bowel disease or intestinal obstruction, severe myelosuppression, bilirubin exceeding the upper limit of 1.5 times, a serious allergic history of irinotecan hydrochloride trihydrate, At the same time, a drug that interacts with irinotecan, such as ketoconazole, is used; (2) The tumor volume accounts for 70% or more of the whole liver or is diffuse, or there are extensive unresectable extrahepatic metastatic lesions; (3) contraindications for embolization surgery: there are hepatic artery-portal shunt, separation from hepatic blood flow, factors that are difficult to perform hepatic artery intubation, such as severe peripheral vascular disease; (4) allergic to contrast agents; (5) bacterial, viral or fungal active infections occurring within 72 hours after enrollment; (6) There are other major operations during the enrollment period or other unrelated drugs need to be taken; (7) The presence of chemotherapy contraindications; (8) The liver function grade is Child-Pugh C grade, which cannot be improved by liver protection treatment; (9) uncorrectable coagulopathy and obvious blood abnormalities, with obvious bleeding tendency; (10) ECOG fitness status score > 2 points (11) combining active infections, especially inflammation of the biliary system; (12) Serious organ diseases such as heart, lung, kidney and brain; (13) Concomitantly diagnosed other sites of malignant tumors; (14) Patients and/or family members do not agree to join clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irinotecan concentration in the tumor tissue;Plasma irinotecan concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Tumor pathological response (including hypoxia response); | — |
Countries
China
Contacts
Public ContactZhou Guofeng
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed