Status:
COMPLETED
TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Liver metastasis is the main reason that affects the survival rates of patients with colorectal cancer (CRLM), and is also the main cause of death of those patients. Especially after the failure of fi...
Detailed Description
Colorectal cancer is one of the most common tumors worldwide, with an annual incidence rate ranking the first in gastrointestinal tract tumors and the third in all malignant tumors in Europe and the U...
Eligibility Criteria
Inclusion
- Patients aged 18-75 years old, gender unlimited;
- Patients with liver metastasis of colorectal cancer by pathological histology or clinical diagnosis (refer to the Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastasis of Colorectal Cancer, 2016 Edition), those who were mainly exposed to liver metastasis with large tumor load and suffered from no clear extrahepatic metastasis;
- Patients with a liver area tumor no more than 5 tumor nodules, and a nodule size no more than10cm;
- Patients subject to the failure of previous chemotherapy regimen containing irinotecan or oxaliplatin after at least six cycles of systemic chemotherapy; they cannot undergo surgery or refuse surgery;
- Patients with liver tumor who did not receive interventional treatment (TACE, ablation, iodine particle treatment, etc.) within one year;
- Patients with an expected survival period longer than 3 months;
- Patients with favorable liver function (7 points for Child-Pugh A or B);
- Patients with a physical fitness ECOG no more than one point;
- Patients who understood and signed the Informed Consent Form.
Exclusion
- Patients with distant metastases except the liver;
- Patients subject to the treatment of TACE, ablation or iodine particles within one year;
- Patients with obvious artero / venous fistula and cancer plugs in the main portal vein;
- Patients who had suffered from or were currently developing other malignant tumors (except for the cured basal or squamous cell skin carcinoma or cervical carcinoma in situ);
- Patients whose white blood cells were less than 3,000 cell / mm3, or platelet count less than 50,000 / mm3;
- Patients subject to renal insufficiency (creatinine\> 2 mg/L);
- Patients whose AST and / or ALT was / were more than 5 times the upper limit of normal;
- Patients with poor coagulation function, an INR larger than 1.5, or currently subject to anticoagulant therapy or known hemorrhagic disease;
- Patients with a history of major disease with heart, kidney, bone marrow, or lung, and central nervous system involvement;
- Patients requiring antibiotic treatment due to recent infections;
- Patients subject to comorbidities or social environment that could prevent them from following the study plan or even endanger their safety.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06071052
Start Date
December 1 2022
End Date
December 31 2024
Last Update
December 8 2025
Active Locations (1)
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1
the first affiliated hospital, Sun-Yat sen university
Guangzhou, Guangdong, China, 510000