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NOT YET RECRUITING
NCT07870772
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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