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| Name | Class |
|---|---|
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
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This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.
Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Bevacizumab, an angiogenesis Inhibitors was effectively used for hepatocelluar carcinama (HCC) therapy. Toripalimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Bevacizumab 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 Bevacizumab and Toripalimab | Experimental | Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks. |
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| 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 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival rate at 6 months | Progression was defined as progressive disease by independent radiologic review according to mRECIST 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfnag Zhou, MD | Contact | 86 19868000115 | zhouqun988509@163.com | |
| Fei Gao, Professor | Contact | gaof@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fei Gao | Sun Yat-sen University | Study Director |
| Kangshun Zhu, Professor | Second Affiliated Hospital of Guangzhou Medical University | Study Director |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | 15mg/kg intravenously every 3 weeks |
|
| 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 |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |