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

NCT07238881 | Recruiting Phase 2 DMC

• 1 other identifier: MA-HCC-II -029
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dalpiciclib; Camrelizumab; second-line treatment

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.

  6 months

Secondary Outcomes (3)

• Overall survival (OS)

  6 months

• Progression free survival (PFS)

  6 months

• Adverse events

  30 days

Study Arms (2)

High-Dalpiciclib +Camrelizumab

EXPERIMENTAL

Dalpiciclib 125mg, qd+Camrelizumab 200mg q2w

Drug: Dalpiciclib Isetionate Tablets; Drug: Camrelizumab (anti-PD-1 inhibitor)

Low-Dalpiciclib +Camrelizumab

EXPERIMENTAL

Dalpiciclib 100mg, qd+Camrelizumab 200mg q2w

Drug: Dalpiciclib Isetionate Tablets; Drug: Camrelizumab (anti-PD-1 inhibitor)

Interventions

Dalpiciclib Isetionate Tablets DRUG

Dalpiciclib 125mg

High-Dalpiciclib +Camrelizumab

Camrelizumab (anti-PD-1 inhibitor) DRUG

Camrelizumab 200mg

High-Dalpiciclib +Camrelizumab; Low-Dalpiciclib +Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
• Barcelona clinic liver cancer-stage C
• Patients who have previously received first-line treatment with ICI treatments (including PD-1/PD-L1/CTLA-4) and who have shown tumor progression as confirmed by imaging studies.
• Eastern Cooperative Oncology Group performance status of 0 to 1
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:
• Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document

You may not qualify if:

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known central nervous system tumors including metastatic brain disease

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

camrelizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CN (1)