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New treatment option for Hepatocellular Carcinoma
Official title Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
ClinicalTrials.gov ID: NCT06478927
What this study is testing
What is Palbociclib capsules?
Palbociclib capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as Palbociclib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients aged ≥18 years and ≤75 years;
- ECOG score 0\~2;
- Patients with histologically or cytologically confirmed unresectable advanced hepatocellular carcinoma;
- Patients who have failed or are intolerant of at least second-line treatment;
- Expected survival ≥ 3 months;
You likely can't join if
- Prior treatment with any CDK4/6 inhibitor drug;
- Patient has received antitumor therapy in another clinical trial within 4 weeks prior to enrollment;
- Patient has undergone a major surgical operation within 4 weeks prior to enrollment or the patient has not fully recovered from such surgical...
- Severe cardiac disease or discomfort;
- Hepatitis B combined with Hepatitis C or Hepatitis D infection;
- Patient is allergic to the components of the drug perphenazine or its excipients;
See the full eligibility criteria
- Patients aged ≥18 years and ≤75 years;
- ECOG score 0\~2;
- Patients with histologically or cytologically confirmed unresectable advanced hepatocellular carcinoma;
- Patients who have failed or are intolerant of at least second-line treatment;
- Expected survival ≥ 3 months;
- An evaluable lesion within 21 days prior to enrollment according to RECIST 1.1 criteria;
- 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;
- Child-Pugh Liver Function Class: Grade A or B (≤7 points);
- 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...
- 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...
- Prior treatment with any CDK4/6 inhibitor drug;
- Patient has received antitumor therapy in another clinical trial within 4 weeks prior to enrollment;
- Patient has undergone a major surgical operation within 4 weeks prior to enrollment or the patient has not fully recovered from such surgical operation;
- Severe cardiac disease or discomfort;
- Hepatitis B combined with Hepatitis C or Hepatitis D infection;
- Patient is allergic to the components of the drug perphenazine or its excipients;
- 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);
- Those with multiple factors affecting the oral administration of drugs (e.g. inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.