drugset / Trial / NCT07238881

Dalpiciclib Plus Camrelizumab for HCC Patients Who Have Previously Received ICI Treatment

NCT07238881

Phase 2 Recruiting 30 enrolled Sun Yat-sen University
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-11-05
Primary completion
2026-12-31
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg
Subject Dalpiciclib Small molecule 100 mg
Subject Dalpiciclib Small molecule 125 mg