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RecruitingNCT06478927Updated Jun 27, 2024

Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib

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

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Jan 2024, registered Jun 2024).
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Palbociclib Group

    Palbociclib capsules, oral, qd

    Drug: Palbociclib capsules

Interventions

  • DrugPalbociclib 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

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Adverse Events (AE)

    AE assessed by NCI-CTCAE V5.0.

    Time frame: up to approximately 2 years.

07

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06478927
Lead sponsor
Henan Cancer Hospital
Responsible party
Sponsor
First posted
Jun 27, 2024
Start date
Jan 15, 2024
Primary completion
Jan 15, 2026 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
Jun 27, 2024

Study contacts

Hao Zhuang, M.D.
Contact
zhh8764@163.com
18603731088
Hao Zhuang, M.D.
principal investigator · Henan Cancer Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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