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Angiogenesis Inhibitor
Control group for Liver Cancer
Phase 3
Waitlist Available
Research Sponsored by Shanghai Junshi Bioscience Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This is a prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab (hereafter referred to as JS001) combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy. The study will use PFS and OS as the co-primary endpoints, with approximately 280 patients planned to be enrolled.
Eligible Conditions
- Liver Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Progression-free survival (PFS)
Secondary study objectives
ADA
Disease Control Rate (DCR)
DoR
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Control groupActive Control1 Intervention
Sorafenib
Group II: Experimental groupActive Control1 Intervention
Toripalimab combined with Bevacizumab
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Who is running the clinical trial?
Shanghai Junshi Bioscience Co., Ltd.Lead Sponsor
114 Previous Clinical Trials
27,442 Total Patients Enrolled
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