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This is a prospective clinical study to investigate the safety and efficacy of anti-PD-1 immunotherapy (Camrelizumab) in patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation. All of the enrolled patients have a background of liver transplantation for HCC. Due to the tumor recurrence, patients are not suitable for curative surgical resection, and targeted therapy provides poor therapeutic effect, leading to tumor progression or intolerance. Before immunotherapy, the PD-L1 expression was confirmed negative in the graft liver by immunohistochemistry, and patients continued targeted therapy as part of a combined antitumor regimen. In addition, the immunosuppression schedule is also reduced to a low level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab treatment | Experimental | Camrelizumab (SHR-1210), 200mg, I.V., Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab treatment | Drug | Camrelizumab (SHR-1210), 200mg, I.V., Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate after Camrelizumab treatment according to the mRECIST | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from the initiation of Camrelizumab treatment to the patient death from any cause | 2 years |
| Progression-free Survival (PFS) | Time from the initiation of Camrelizumab treatment to radiological tumor progression or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoying Wang, M.D. | Contact | +86-13632407313 | wanggy3@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | 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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| 2 years |
| Time to Progression (TTP) | Time from the initiation of Camrelizumab treatment to radiological tumor progression | 2 years |
| Serious Adverse Event (SAE) | The incidence of serious adverse event caused by Camrelizumab treatment | 2 years |
| Graft Rejection (GR) | The incidence of graft rejection during the Camrelizumab treatment | 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |