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The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (HCC)
Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated HAIC plus lenvatinib and toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC plus Lenvatinib and Toripalimab | Experimental | Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 240mg intravenously every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic arterial infusion chemotherapy | Procedure | administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival rate at 6 months | Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is the length of time from the date of randomization until death from any cause. | 6 months |
| Progression free survival (PFS) | PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause. |
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Inclusion Criteria:
Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits 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 | Guangzhou | Guangdong | 510060 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 |
|---|---|
| C531958 | lenvatinib |
| C000656314 | toripalimab |
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| Lenvatinib | Drug | 12 mg (or 8 mg) once daily (QD) oral dosing. |
|
| Toripalimab | Drug | 240mg intravenously every 3 weeks |
|
| 6 months |
| Objective response rate (ORR) | ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR. | 6 months |
| Adverse events | Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report. | 6 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |