A Single-Arm, Prospective, Open Clinical Study of Palbociclib for Backline Treatment of Advanced Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients aged ≥18 years and ≤75 years;

• ECOG score 0\

‣ 2;

• Patients with histologically or cytologically confirmed unresectable advanced hepatocellular carcinoma;

• Patients who have failed or are intolerant of at least second-line treatment;

• Expected survival ≥ 3 months;

• An evaluable lesion within 21 days prior to enrollment according to RECIST 1.1 criteria;

• 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;

• Child-Pugh Liver Function Class: Grade A or B (≤7 points);

• 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;

⁃ CNS metastases without clinical symptoms or with clinical symptoms controlled and stabilized for ≥4 weeks after treatment:

‣ (1) Routine blood tests should meet the following criteria: ANC ≥1.0×109/L; PLT ≥50×109/L; Hb ≥80 g/L; (2) Biochemical tests must meet the following criteria: TBIL ≤ 3 times the upper limit of normal (ULN); ALT and AST ≤ 5 times the upper limit of normal (ULN); serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 50 ml/min (Cockcroft-Gault formula); (3) Coagulation examination criteria to be met: prothrombin time (PT) ≤ 1.5 x ULN, activated partial thromboplastin kinase time (aPTT) ≤ 1.5 x ULN; (4) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF ≥ 55%), ECG QTc \< 450ms (men), QTc \< 470ms (women); 13. Patients who agree to abstain from sex or use an effective method of contraception for the duration of treatment and for at least 7 months after the last dose of study treatment; 14. Signed informed consent.

Locations
Other Locations
China
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Hao Zhuang, M.D.
zhh8764@163.com
18603731088
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 22
Treatments
Experimental: Palbociclib Group
Palbociclib capsules, oral, qd
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov