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This study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma. Blood samples were obtained during the course of treatment to measure the relative parameter. All Investigational Medicinal Products (IMP) were discontinued after the total cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2524 plus bevacizumab group | Experimental | SHR-2524 plus bevacizumab combined with other drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2524 Injection | Drug | SHR-2524 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough serum concentrations (C21d) | Pharmacokinetics (PK) parameters. | 0 - 21 days. |
| Area under curve from Day 0 to Day 21 (AUC0-21d) | Pharmacokinetics (PK) parameters. | 0 - 12 days. |
| Area under curve up to 21 weeks (AUC0-21weeks) | Pharmacokinetics (PK) parameters. | 0 - 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum blood concentration (Cmax) | Pharmacokinetics (PK) parameters. | About 9 months. |
| Time to peak concentration (Tmax) | Pharmacokinetics (PK) parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wu | Contact | +86-0518-82342973 | yang.wu.yw96@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350002 | China |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab Injection |
| Drug |
Bevacizumab injection. |
|
| About 9 months. |
| Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t) | Pharmacokinetics (PK) parameters. | About 9 months. |
| Area under curve - Time curve from Time 0 to Infinity (AUC0-∞) | Pharmacokinetics (PK) parameters. | About 9 months. |
| Elimination half-life (t1/2) | Pharmacokinetics (PK) parameters. | About 9 months. |
| Rate of clearance (CL/F) | Pharmacokinetics (PK) parameters. | About 9 months. |
| Geometric mean of the apparent volume of distribution of the population (Vz/F) | Pharmacokinetics (PK) parameters. | About 9 months. |
| The number and percentage of anti-drug antibody (ADA) positive participants | Immunogenicity parameter. | About 9 months. |
| Adverse events (AEs) | Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of adverse events (AEs). | About 9 months. |
| Serious adverse events (SAEs) | Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of serious adverse events (SAEs). | About 9 months. |
| Investigator - assessed objective response rate (ORR) based on RECIST v1.1 | Efficacy parameters. | About 9 months. |
| Investigator - assessed duration of response (DoR) based on RECIST v1.1 | Efficacy parameters. | About 9 months. |
| Investigator - assessed disease control rate (DCR) based on RECIST v1.1 | Efficacy parameters. | About 9 months. |
| Investigator - assessed progression-free survival (PFS) based on RECIST v1.1 | Efficacy parameters. | About 9 months. |
| Investigator - assessed overall survival (OS) based on RECIST v1.1 | Efficacy parameters. | About 9 months. |
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |