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This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infusional FOLFOX | Experimental | Infusional mFOLFOX7 plus Camrelizumab and apatinib |
|
| HAIC-FOLFOX | Active Comparator | HAIC-FOLFOX plus Camrelizumab and apatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous FOLFOX7 plus Camrelizumab and apatinib | Drug | Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg,po,qd for every 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 6-mon PFSR | The incidence of disease progression within the first 6 months of the patient's treatment | up to approximately 3 years |
| Hepatic Reserve Function Impairment Rate(ICG-15min) | ICG-R15 is a clinical parameter that assesses the volume of remaining functional hepatocytes, which reflects the functional reserve status of the liver. It is the most commonly used indicator for measuring the severity of liver damage. | up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| mORR | objective response rate based on mRECIST | up to approximately 3 years |
| ORR | objective response rate based on RECISTv1.1 | up to approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunxiuxiu Xu, MD | Contact | 17722864609 | xuyxx@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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arm1: infusional FOLFOX plus Camrelizumab and apatinib arm2: HAIC-FOLFOX plus Camrelizumab and apatinib
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|
| HAIC-FOLFOX plus Camrelizumab and apatinib | Drug | 2-h infusion of oxaliplatin at 85 mg/m2 ,a 2-3-h administration of leucovorin at 200 mg/m2 , Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h. Camrelizumab (200 mg intravenously, commencing in 7 days after the first HAIC cycle and repeated every 21 days) and apatinib (250 mg daily, taken orally, beginning in 7 days after the initial HAIC cycle). Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg,po,qd for every 21 days. |
|
| DOR | Proportion of patients who achieved complete response (CR) or partial response (PR) at the end of treatment, based on mRECIST criteria. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase. | up to approximately 3 years |
| DCR | The percentage of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable (SD) cases. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase. | up to approximately 3 years |
| 1y-PFSR | The proportion of patients who did not develop tumor progression from enrollment to 1 year of follow-up. | 1 year |
| 2y-OSR | Proportion of patients surviving from the start of enrollment to the full 2 years of follow-up. | 2 year |
| OS | The time between the start of treatment and the patient's death | up to approximately 5 years |
| TRAE | The classification of adverse events during treatment was based on NCI-CTCAE v5.0 criteria. | up to approximately 3 years |
| conversion rate | rate of unresectable converted into resectable | up to approximately 3 years |
| PFS | The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1. | up to approximately 3 years |
| 9-mon PFSR | The incidence of disease progression within the first 9 months of the patient's treatment | up to approximately 3 years |
| 18-mon OSR | Proportion of patients surviving from the start of enrollment to the full 18 months of follow-up. | 2 years |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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