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

NCT07238881 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-20

No results posted yet for this study

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

DRUG

Dalpiciclib Isetionate Tablets

Dalpiciclib 125mg

DRUG

Dalpiciclib Isetionate Tablets

Dalpiciclib 100mg

DRUG

Camrelizumab (anti-PD-1 inhibitor)

Camrelizumab 200mg

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2026-12-31
Completion
2027-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07238881 on ClinicalTrials.gov