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

Conditions

• Hepatocellulcar Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Dalpiciclib Isetionate Tablets — DRUG
  Dalpiciclib 125mg
• Dalpiciclib Isetionate Tablets — DRUG
  Dalpiciclib 100mg
• Camrelizumab (anti-PD-1 inhibitor) — DRUG
  Camrelizumab 200mg

Study Details

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.

Key Dates

Start date

Nov 5, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Jun 1, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: High-Dalpiciclib +Camrelizumab
  Dalpiciclib 125mg, qd+Camrelizumab 200mg q2w
• Experimental: Low-Dalpiciclib +Camrelizumab
  Dalpiciclib 100mg, qd+Camrelizumab 200mg q2w

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 6 months ]