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This is an open-label, single-arm, national multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with Bevacizumab as the first-line therapy for advanced HCC The study will use safety/tolerability and ORR as the primary study objectives and indicators, and plans to enroll about 50-60 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Experimental group: Toripalimab combined with Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab combined with Bevacizumab | Combination Product | Experimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 15 mg/kg (IV infusion, every 3 weeks (q3w).. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency table will be used to summarize occurrence of each treatment-emergent AE | Up to 2 years |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number and incidence of abnormal laboratory examinations by treatment group. | Up to 2 years |
| ORR | The rate of participants that achieve either a complete response (CR) or a partial response (PR). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DoR | The time from the first assessment of CR or PR to the first assessment of PD or death due to any cause. | Up to 2 years |
| DCR | The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable. |
| Measure | Description | Time Frame |
|---|---|---|
| PD-L1 | Correlation between PD-L1 expression level in tumor tissue, proportion of strong positive expression of PD-L1 | Up to 2 years |
| TMB | Correlation betweenTumor mutation burden (TMB) and the efficacy |
"The patients meeting all the following inclusion criteria can be enrolled in this study:
Patients can not be enrolled in the study if any one of the following criteria is fulfilled:
20. Known history of serious allergy to any monoclonal antibody, anti-angiogenesis targeted drug.
"
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer hospital | Beijing | China |
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|
| Up to 2 years |
| TTP | time from the start of treatment to progression of diease. | Up to 2 years |
| PFS | PFS is defined as time from the start of treatment to progression of disease or death. | Up to 2 years |
| Overall survival (OS) | Overall survival is defined as time from the start of treatment until death due to any reason. | Up to 2 years |
| Up to 2 years |
| PK | Pharmacokinetic profile in HCC patients of observed maximum plasma concentration | Up to 2 years |
| ADA | Analysis of anti-drug antibody (ADA) during treatment. | Up to 2 years |
| ID | Term |
|---|---|
| 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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