Dalpiciclib Plus Camrelizumab for HCC Patients Who Have Previously Received ICI Treatment
A Prospective, Randomized, Two-Cohort, Exploratory Clinical Study of Dalpiciclib Combined With Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors
Sun Yat-sen University
30 participants
Nov 5, 2025
INTERVENTIONAL
Conditions
Summary
While immune-based therapies (including targeted-immune or dual-immune regimens) have become first-line standard for advanced hepatocellular carcinoma (HCC), there is a lack of high-level evidence to guide second-line treatment after progression on immune checkpoint inhibitors (ICIs). Preclinical studies suggest synergistic antitumor activity between CDK4/6 inhibitors and PD-1/PD-L1 blockade. However, no clinical studies have yet evaluated the combination of dalpiciclib and camrelizumab in this setting. To address this unmet need and explore novel second-line strategies for advanced HCC, we plan to conduct an exploratory clinical trial investigating the efficacy and safety of dalpiciclib plus camrelizumab in patients with unresectable HCC previously treated with ICIs.
Eligibility
Plain Language Summary
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Interventions
Dalpiciclib 125mg
Dalpiciclib 100mg
Camrelizumab 200mg
Locations(1)
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NCT07238881