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| Name | Class |
|---|---|
| First People's Hospital of Foshan | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Affiliated Hospital of Guangdong Medical University | OTHER |
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Compare the efficacy and safety of camrelizumab, apatinib plus FOLFOX-HAIC and camrelizumab plus apatinib in hepatocellular carcinoma with portal vein invasion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab, Apatinib Plus FOLFOX-HAIC | Experimental |
| |
| Camrelizumab and Apatinib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX-HAIC | Procedure | Hepatic arterial infusion of oxaliplatin (85mg/m2,IA,day 1, hour 0-2), fluorouracil (400mg/m2,IA,day 1, hour 3), leucovorin (400mg/m2, IV,day 1, hour 2-3) and fluorouracil (2400mg/m2, IA, hour 3-23) repeated every 4 weeks for a total of six times |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the The date of randomization to death from any cause | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The date from randomization until progression according to RECIST 1.1 or death. from any cause | 2 months |
| Time to progression | The time from randomization until first evidence of disease progression. |
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Inclusion Criteria:
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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| 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 |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| Shandong Provincial Hospital |
| OTHER_GOV |
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| Camrelizumab | Drug | Camrelizumab was administered 200mg intravenously for 30-60 minutes every 2 weeks, and the maximum cumulative duration of Camrelizumab is 2 years. The shortest time interval between two administrations should not be less than 12 days. |
|
| Apatinib | Drug | Apatinib was administered orally 250mg once per day |
|
| 2 months |
| Time to response | The time from initiating treatment to achieve complete or partial response according to RECIST 1.1 | 2 months |
| Duration of response | The time from randomization to disease progression or death in patients who achieve complete or partial response according to RECIST 1.1 | 2 months |
| Objective response rate | The proportion of patients with the best response of complete response or partial response according to RECIST 1.1 | 2 months |
| Disease control rate | The proportion of patients with the best response of complete response, partial response and stable disease according to RECIST 1.1 | 2 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |