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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellulcar Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07238881

MA-HCC-II -029

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

High-Dalpiciclib +Camrelizumab

Experimental group

Description:

Dalpiciclib 125mg, qd+Camrelizumab 200mg q2w

Treatment:

Drug: Dalpiciclib Isetionate Tablets

Drug: Dalpiciclib Isetionate Tablets

Drug: Camrelizumab (anti-PD-1 inhibitor)

Low-Dalpiciclib +Camrelizumab

Experimental group

Description:

Dalpiciclib 100mg, qd+Camrelizumab 200mg q2w

Treatment:

Drug: Dalpiciclib Isetionate Tablets

Drug: Dalpiciclib Isetionate Tablets

Drug: Camrelizumab (anti-PD-1 inhibitor)