Clinical Trial

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

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07238881
Lead Sponsor Sun Yat-sen University
Conditions Hepatocellulcar Carcinoma
Enrollment 30 participants
Start Date 2025-11-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-20