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It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE combined with Camrelizumab | Experimental | Camrelizumab(200mg q3w ivgtt)combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE combined with Camrelizumab | Drug | Camrelizumab(200mg q3w ivgtt) combined with TACE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | the time from enrollment to the first disease progression or death from any cause | an expected average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | the time from enrollment to the first disease progression | An expected average of 8 months |
| Overall survival | the time from enrollment to the death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan zhiping, M.D. | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Interventional Radiology, Zhongshan Hospital, Fudan University. | Shanghai | Shanghai Municipality | 200032 | 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 |
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| TACE plus Camrelizumab | Procedure | Camrelizumab(200mg q3w ivgtt) combined with TACE |
|
| An expected average of 24 months |
| Objective response rate | evaluated by investigators with mRECIST | An expected average of 8 months |
| Disease control rate | evaluated by investigators with mRECIST | An expected average of 8 months |
| Duration of response | evaluated by investigators with mRECIST | An expected average of 8 months |
| The incidence of AEs and SAEs by NCI-CTCAE v5.0 | Safety index | An expected average of 8 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |