Using Palbociclib for Advanced Liver Cancer Treatment

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

This study is testing if the drug palbociclib can help people with advanced liver cancer who haven't had success with other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06478927 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable advanced hepatocellular carcinoma who have failed prior treatments.

Not a fit: Patients with early-stage liver cancer or those who have not yet undergone second-line treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hepatocellular carcinoma who have limited treatment choices.

How similar studies have performed: While the use of CDK4/6 inhibitors in other cancers has shown promise, this specific application in advanced hepatocellular carcinoma is relatively novel and untested.

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 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 this trial is running

Zhengzhou, Henan

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Hao Zhuang, M.D. — Henan Cancer Hospital
• Study coordinator: Hao Zhuang, M.D.

Conditions Hepatocellular Carcinoma