Using Palbociclib for Advanced Liver Cancer Treatment

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 clinical trial investigates the use of palbociclib, a CDK4/6 inhibitor, as a backline treatment for patients with advanced hepatocellular carcinoma. The study is a single-arm, prospective, open-label trial involving 22 patients who have previously failed or are intolerant to at least second-line treatments. The efficacy and safety of palbociclib will be assessed through various clinical endpoints, including progression-free survival and overall response rate. The goal is to validate the potential role of CDK4/6 inhibitors in treating this challenging cancer.

Why it matters

Who can join: the full rules

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 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.

Exclusion Criteria:

1. Prior treatment with any CDK4/6 inhibitor drug;
2. Patient has received antitumor therapy in another clinical trial within 4 weeks prior to enrollment;
3. Patient has undergone a major surgical operation within 4 weeks prior to enrollment or the patient has not fully recovered from such surgical operation;
4. Severe cardiac disease or discomfort;
5. Hepatitis B combined with Hepatitis C or Hepatitis D infection;
6. Patient is allergic to the components of the drug perphenazine or its excipients;
7. Other malignant tumors within 5 years (except cured basal cell carcinoma of the skin, carcinoma in situ of the prostate and carcinoma in situ of the cervix);
8. Those with multiple factors affecting the oral administration of drugs (e.g. inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
9. Pregnant or breastfeeding female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing potential who are unwilling to use effective contraception throughout the trial period and for 7 months after the final study dose;
10. Severe concomitant disease or other co-morbidities that would interfere with planned therapy, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Hao Zhuang, M.D. — Henan Cancer Hospital
• Study coordinator: Hao Zhuang, M.D.
• Email: zhh8764@163.com
• Phone: 18603731088

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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.