Dalpiciclib plus camrelizumab for advanced liver cancer after prior immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an exploratory phase 2 interventional trial giving patients a CDK4/6 inhibitor (dalpiciclib) together with the anti–PD‑1 antibody camrelizumab to characterize safety and antitumor activity. Eligible participants have unresectable hepatocellular carcinoma, measurable disease, prior progression on immune checkpoint inhibitors, ECOG performance status 0–1, and Child‑Pugh class A liver function. The trial will monitor imaging-based tumor responses, safety labs, and adverse events while patients receive the combination regimen. Conducted at Sun Yat‑sen University Cancer Center, the study aims to generate preliminary efficacy signals to inform larger studies.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.