A Phase II, Single-arm, Open-label Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced HCC

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country190 target enrollmentMarch 8, 2018

ConditionsHepatocellular Carcinoma

InterventionsSHR 1210+apatinib

DrugsSHR 1210+apatinib

Overview

Phase: Phase 2
Intervention: SHR 1210+apatinib
Conditions: Hepatocellular Carcinoma
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 190
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to observe and preliminary explore the efficacy and safety of combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma.

Detailed Description

SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). Patients with advanced HCC who failed or intolerable to sorafenib will receive apatinib 250mg orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.

Registry

clinicaltrials.gov

Start Date

March 8, 2018

End Date

March 10, 2021

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18 years old, both genders.
•Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.
•Liver function status Child-Pugh Class A.
•Barcelona Clinic Liver Cancer stage Category B or C.
•Failure or intolerance to prior treatment with targeted therapy.
•Eastern Cooperative Oncology Group Performance Status of 0 or
•Life expectancy of at least 12 weeks.
•Adequate bone marrow, liver and renal function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment).

Exclusion Criteria

•Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
•Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
•More than one regimen.
•Known history of hypersensitivity to any components of the SHR-1210 formulation, or other antibody formulation.
•Known or occurrence of central nervous system (CNS) metastases or hepatic encephalopathy.
•Patients with tumor burden ≥50% of the liver volume or received liver transplantation.
•Patients with clinical symptoms of ascites.
•Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.
•Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class \> 2), ventricular arrhythmia which need medical intervention.
•Coagulation abnormalities (INR\>2.0、PT\>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.

Arms & Interventions

SHR-1210+Apatinib

Patients will receive apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Intervention: SHR 1210+apatinib

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: Up to approximately 12 months

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Secondary Outcomes

Duration of Response (DoR)(Up to approximately 12 months)
Disease Control Rate (DCR)(Up to approximately 12 months)
Time to Objective Response(TTR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).(Up to approximately 12 months)
9-month Survival Rate(Up to approximately 9 months)
12-month Survival Rate(Up to approximately 12 months)
Overall Survival(OS)(Up to approximately 36 months)
Progression-free Survival(PFS)(Up to approximately 12 months)