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Dalpiciclib Plus Camrelizumab for HCC Patients Who Have Previously Received ICI Treatment
Sponsor: Sun Yat-sen University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-11-05
Completion Date
2027-06-01
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Dalpiciclib Isetionate Tablets
Dalpiciclib 125mg
Dalpiciclib Isetionate Tablets
Dalpiciclib 100mg
Camrelizumab (anti-PD-1 inhibitor)
Camrelizumab 200mg
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China