Hepatocellular carcinoma
Conditions
Interventions
experimental group:Palbociclib
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged = 18 years and = 75 years old; 2. ECOG score 0-2 points; 3. Patients with unresectable advanced hepatocellular carcinoma confirmed by histology or cytology; 4. Patients who have failed or become intolerant to at least second-line treatment; 5. Expected survival time = 3 months; According to RECIST 1.1 standard, there are evaluable lesions within 21 days prior to enrollment; 7. Barcelona clinical liver cancer staging (BCLC staging) B or C stage, and not suitable for surgery or local treatment, or progression after surgery or local treatment; 8. Child Pugh liver function grading: A or B grade (= 7 points); 9. HBV DNA quantification must be50ml/min (Cockcroft Gault formula); (3) The coagulation test standard should comply with: prothrombin time (PT) = 1.5 × ULN, activated partial thromboplastin kinase time (aPTT) = 1.5x ULN; (4) Cardiac ultrasound and echocardiography: Left ventricular ejection fraction (LVEF = 55%), electrocardiogram QTc = 450ms (male), QTc = 470ms (female); 13. Patients who agree to abstain or use effective contraceptive methods during the treatment period and at least 7 months after the last dose in the study treatment; 14. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously treated with any CDK4/6 inhibitor drugs; 2. Received anti-tumor therapy in other clinical trials within 4 weeks prior to enrollment; 3. Has undergone significant surgical procedures within the 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures; 4. Severe heart disease or discomfort; 5. hepatitis B combined with hepatitis C or hepatitis D infection; 6. Allergies to the ingredients or excipients of piperacillin; 7.Suffering from other malignant tumors within 7.5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the prostate, and carcinoma in situ of the cervix); 8. Individuals with multiple factors that affect oral medication, such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, and intestinal obstruction; 9. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures throughout the entire trial period and within 7 months after the last study medication; 10. Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactZheng Lu
Henan Cancer Hospital
Outcome results
None listed