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SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label#single center #non-randomized #Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with advanced stage hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210+ apatinib | Experimental | SHR-1210 was administered intravenously (without prophylaxis) at a fixed dose of 200 mg for 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 2 years; Apatinib was taken orally after meals, once a day, for continuous medication, and 1 cycle every 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Evaluated by researchers based on the RECIST 1.1 standard | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) | Evaluated by researchers based on the RECIST 1.1 standard | 2 years |
| To the relief time (TOR) | Evaluated by researchers based on the RECIST 1.1 standard |
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Inclusion Criteria:
Exclusion Criteria:
- 1.The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2.The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization 5.Arterial/venous thrombosis in the first 6 months of randomization 6.According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.,with family or social factors, it will affect the safety of patients.
7.Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fan, PHD | Contact | 021 64041990/680774 | :fan.jia@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | 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 |
| C000711728 | spartalizumab |
| C553458 | apatinib |
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| apatinib | Drug | Apatinib is a selective VEGFR2 inhibitor. |
|
| 2 years |
| Duration of relief(DOR) | Evaluated by researchers based on the RECIST 1.1 standard | 2 years |
| Disease Control Rate (DCR) | Evaluated by researchers based on the RECIST 1.1 standard | 2 years |
| 9-month survival rate | 9-month |
| 12-month survival rate | 12-month |
| Overall survival (OS) | 10 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |