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Lenvatinib Plus Bevacizumab and PD-1 Inhibition Versus Bevacizumab Plus PD-1 Inhibition After Progression on Bevacizumab Plus Sintilimab in Unresectable Hepatocellular Carcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study
Sponsor: Sun Yat-sen University
Summary
This retrospective study looks at patients with unresectable hepatocellular carcinoma whose cancer progressed after treatment with bevacizumab plus sintilimab. The study compares two treatment approaches used after progression: lenvatinib plus bevacizumab and a PD-1 inhibitor, versus bevacizumab plus a PD-1 inhibitor alone. We will compare how well these treatments control the cancer, how long patients remain free from disease progression, overall survival, and treatment-related side effects. All information will be collected from existing medical records. No additional tests, treatments, or visits are required because of this study. Patient information will be de-identified and kept confidential. The goal of this study is to better understand whether adding lenvatinib may improve outcomes after bevacizumab plus sintilimab treatment has stopped working, and to provide evidence that may help guide future treatment decisions.
Official title: Comparative Efficacy and Safety of Lenvatinib Plus Bevacizumab and a PD-1 Inhibitor Versus Bevacizumab Plus a PD-1 Inhibitor After Progression on Bevacizumab Plus Sintilimab in Unresectable Hepatocellular Carcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-31
Completion Date
2027-07-31
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Intensified Treatment
Bevacizumab, 15mg/kg, iv drip, q3w; PD-1 Inhibitor, 200mg/dose, iv drip, q3w; Lenvatinib, for weight ≤60 kg, 8 mg/d, po, qd; for weight \>60 kg, 12 mg/d, po, qd.
Continued Treatment
Bevacizumab, 15mg/kg, iv drip, q3w; PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab), 200mg/dose, iv drip, q3w.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China