RecruitingPhase 2NCT07238881

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


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — dalpiciclib (a cell-growth blocker) and camrelizumab (an immunotherapy drug) — for people with advanced liver cancer who have already tried immunotherapy but whose cancer continued to grow. **You may be eligible if...** - You have been diagnosed with hepatocellular carcinoma (the most common type of liver cancer) - Your liver cancer has reached an advanced stage (Barcelona stage C) - You previously received immunotherapy (a PD-1, PD-L1, or CTLA-4 inhibitor) but your cancer progressed - You have at least one measurable tumor - You are in reasonably good physical condition (ECOG score 0 or 1) - You have no cirrhosis or mild cirrhosis only (Child-Pugh class A) - Your blood counts and organ function meet study requirements **You may NOT be eligible if...** - Your liver cancer can be removed by surgery or treated with local ablation - You have moderate-to-severe liver cirrhosis (Child-Pugh B or C) - Your blood counts or organ function are below required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalpiciclib Isetionate Tablets

Dalpiciclib 125mg

DRUGDalpiciclib Isetionate Tablets

Dalpiciclib 100mg

DRUGCamrelizumab (anti-PD-1 inhibitor)

Camrelizumab 200mg


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07238881


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