NCT03764293
Completed
Phase 3
A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
Overview
- Phase
- Phase 3
- Intervention
- SHR-1210
- Conditions
- Locally Advanced or Metastatic and Unresectable HCC
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 543
- Locations
- 121
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histopathologically or cytologically confirmed advanced HCC
- •No previous systematic treatment for HCC
- •Have at least one measurable lesion (in accordance with RECIST v1.1)
- •BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
- •ECOG-PS score 0 or 1
- •Child-Pugh Class: Grade A
- •Life Expectancy of at least 12 weeks
- •Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
- •Subjects with HCV-RNA(+) must receive antiviral therapy
- •Adequate organ function
Exclusion Criteria
- •Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
- •Moderate-to-severe ascites with clinical symptoms
- •History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- •Known genetic or acquired hemorrhage or thrombotic tendency
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- •Cardiac clinical symptom or disease that is not well controlled
- •Hypertension that can not be well controlled through antihypertensive drugs
- •Factors to affect oral administration
- •History of hepatic encephalopathy
Arms & Interventions
SHR-1210
SHR-1210+Apatinib
Intervention: SHR-1210
SHR-1210
SHR-1210+Apatinib
Intervention: Apatinib
Control
Sorafenib
Intervention: Sorafenib
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Up to approximately 3 years
OS was defined as the time from randomization to death from any cause.
Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1
Time Frame: Up to approximately 3 years
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Disease Control Rate (DCR)(Up to approximately 3 years)
Study Sites (121)
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