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Trial Title:
Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
NCT ID:
NCT06478927
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Palbociclib
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Palbociclib Capsules
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Palbociclib capsules
Description:
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.
Arm group label:
Palbociclib Group
Other name:
Palbociclib
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Zhuang, M.D.
Phone:
18603731088
Email:
zhh8764@163.com
Start date:
January 15, 2024
Completion date:
January 15, 2027
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478927
