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To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200mg IV d1,Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 | Up to 3 years |
| Overall survival (OS) | Defined as the time from the date of treatment start to the date of death | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Defined as proportion of patients who have a best response of CR or PR | Up to 1 years |
| Disease control rate (DCR) | Defined as proportion of patients who have a best response of CR, PR or SD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huikai Li | Contact | 862223340123 | 3091 | lihuikai@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Bevacizumab | Drug | 7.5mg/kg IV d1,Q3W |
|
| Liver Protective Support Therapy | Combination Product | Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy |
|
| Up to 1 years |
| Quality of Life (QoL) | The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0) | Up to 3 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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