An interventional study of Palbociclib capsules in Hepatocellular Carcinoma, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by Henan Cancer Hospital · Not applicable, Interventional, and Treatment
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.
This study was a single arm, prospective, open clinical study. Twenty-two patients with advanced hepatocellular carcinoma were enrolled in this study and were simultaneously treated and observed with palbociclib. The efficacy and safety of palbociclib in patients with advanced hepatocellular carcinoma were evaluated by PFS, ORR, DCR, OS, and AE.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 22 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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.
Exclusion Criteria:
Palbociclib capsules, oral, qd
Drug: Palbociclib capsules
Palbociclib capsules, oral, 125 mg/dose, qd, take 3 weeks and then stop for 1 week, 28d for one treatment cycle until disease progression or intolerable toxicity.
Also known as: Palbociclib
Progression-free survival (PFS)
PFS is defned as the time from randomization untlthe date of first occurence of investigator assessed radiolbgical disease progression or death due to any cause,whichever came first.
Time frame: up to approximately 2 years.
Objective response rate (ORR)
ORR is defied as the percentage of subject with complete response (CR) or partial response (PR) by investigator assessment per REclsT criteria, version 1.1.
Time frame: up to approximately 2 years.
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD).
Time frame: up to approximately 2 years.
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: up to approximately 2 years.
Adverse Events (AE)
AE assessed by NCI-CTCAE V5.0.
Time frame: up to approximately 2 years.
Plan to share: No
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Henan Cancer Hospital