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| Name | Class |
|---|---|
| Guangzhou No.12 People's Hospital | OTHER_GOV |
| First People's Hospital of Foshan | OTHER |
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Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin&5-fluorouracil was effective in unresectable hepatocellular carcinoma (HCC). The program of FOLFOX-HAIC in HCC was performed for 1 day (HAIC 1d) or 2 days (HAIC 2d). We hereby retrospectively compared the efficacy and safety between these two treatment regimens, and explored the predictive power of thymidylate synthase (TYMS), an enzyme involved in the DNA synthesis process and metabolism of fluorouracil. Patients with HCC staged BCLC A-B receive HAIC only, and patients with HCC staged BCLC C receive HAIC plus systemic treatment, such as sorafenib, A+T, lenvatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC 1d | Experimental | Oxaliplatin, leucovorin, and bolus fluorouracil were conducted equally in the both groups, while infusional fluorouracil 2400 mg/m² was given over 23 hours in the HAIC 1d group |
|
| HAIC 2d | Active Comparator | Oxaliplatin, leucovorin, and bolus fluorouracil were conducted equally in the both groups, while infusional fluorouracil 2400 mg/m² was given over 46 hours in the HAIC 2d group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC | Procedure | The microcatheter was advanced into the hepatic artery, and patients were transferred to the inpatient ward for drug infusion via the hepatic artery |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | time from randomzation to death | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | time from randomzation to progression or death, which occur firstly. | 12 months |
| objective response rate per RECIST 1.1 | CR plus PR per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Foshan | Recruiting | Foshan | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
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| FOLFOX 2d | Drug | Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 46 hours |
|
| FOLFOX 1d | Drug | Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 23 hours |
|
| 12 months |
| Adverse Events | Adverse Events according to CTCAE 4.0 | 30 days |
| the predictive power of thymidylate synthase (TYMS) | the correlation between thymidylate synthase (TYMS) and survival. Whether the survival of patients with low TYMS is better than those with high TYMS | 12 months |
| Cancer Center Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Guangzhou Twelfth People 's Hospita | Recruiting | Guangzhou | Guangdong | 510620 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |