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| Name | Class |
|---|---|
| Kaiping Central Hospital | OTHER |
| Guangzhou No.12 People's Hospital | OTHER_GOV |
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Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-fu 2400 | Active Comparator |
| |
| 5-fu 1200 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2400 mg/m² 5-fu | Drug | Hepatic arterial infusion of oxaliplatin,leucovorin and 2400 mg/m² 5-FU |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 24 months | |
| objective response rate | 6 months | |
| disease control rate |
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Inclusion Criteria:
Age range from 18-75 years;
KPS≥70;
The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
Patients must have at least one tumor lesion that can be accurately measured;
Diagnosed as unresectable with consensus by the panel of liver surgery experts;
No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
Ability to understand the protocol and to agree to and sign a written informed consent document.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| 1200 mg/m² 5-fu |
| Drug |
Hepatic arterial infusion of oxaliplatin,leucovorin and 1200 mg/m² 5-FU |
|
| 6 months |
| Adverse Events | 30 Days after HAIC |
| Guangzhou Twelfth People 's Hospita | Recruiting | Guangzhou | Guangdong | 510620 | China |
|
| Kaiping Central Hospital | Recruiting | Kaiping | Guangdong | 529300 | China |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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