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RECRUITING
NCT07238881
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

Dalpiciclib Isetionate Tablets

Dalpiciclib 125mg

DRUG

Dalpiciclib Isetionate Tablets

Dalpiciclib 100mg

DRUG

Camrelizumab (anti-PD-1 inhibitor)

Camrelizumab 200mg

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China