At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 344 enrolled
Drug / intervention
IBI310 +2 moredrug
Likely dose
Sorafenib 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma
In Brief
A Phase 3 clinical trial evaluating IBI310, Sintilimab, and 1 other intervention for Hepatocellular Carcinoma. Completed, enrolled 344 participants across 1 site.
Detailed Summary
This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartFeb 2021
Primary CompletionDec 2025
TodayJul 2026
First PostedJan 22, 2021
Enrollment StartFeb 7, 2021
Primary CompletionDec 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 5.4 years ago
Interventions
IBI310drug
IBI310 IV d1, Q6W
Sintilimabdrug
sintilimab IV d1, Q3W
Sorafenibdrug
Sorafenib 400mg po