NCT07238881

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellulcar Carcinoma

Interventions

Type	Name	Description
DRUG	Dalpiciclib Isetionate Tablets	Dalpiciclib 125mg
DRUG	Dalpiciclib Isetionate Tablets	Dalpiciclib 100mg
DRUG	Camrelizumab (anti-PD-1 inhibitor)	Camrelizumab 200mg

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-12-31
• Completion: 2027-06-01
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: China