Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
Trial Parameters
Brief Summary
Currently, it has been demonstrated that CDK4 is highly expressed in hepatocellular carcinoma patients and is significantly associated with poor prognosis in hepatocellular carcinoma patients. Palbociclib is the world's first marketed inhibitor of the cell cycle protein-dependent kinase CDK4/6, which is capable of blocking cell cycle progression and inhibiting tumor cell proliferation. However, current evidence for the use of CDK4/6 inhibitors in patients with advanced hepatocellular carcinoma cells remains lacking. This study used palbociclib backline treatment for patients with advanced hepatocellular carcinoma, aiming to further validate the potential role of CDK4/6 inhibitors in the treatment of patients with advanced hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥18 years and ≤75 years; 2. ECOG score 0\~2; 3. Patients with histologically or cytologically confirmed unresectable advanced hepatocellular carcinoma; 4. Patients who have failed or are intolerant of at least second-line treatment; 5. Expected survival ≥ 3 months; 6. An evaluable lesion within 21 days prior to enrollment according to RECIST 1.1 criteria; 7. Barcelona Clinical Liver Cancer Staging (BCLC staging) stage B or C and not suitable for surgical or local treatment, or progression after surgery or local treatment; 8. Child-Pugh Liver Function Class: Grade A or B (≤7 points); 9. HBV DNA quantification must be \<500IU/ml or 2500 copies/ml and receive at least 2 weeks of anti-HBV treatment before study entry; HCVRNA quantification-positive patients must have completed antiviral treatment at least 1 month before study entry; 10. CNS metastases without clinical symptoms or with clinical symptoms controlled and stabilized for ≥4 weeks after treatm