Hepatocellular CarcinomaNCT06478927
Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib
A study testing Palbociclib capsules in people with Hepatocellular Carcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Palbociclib capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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 1 month before study entry;
- CNS metastases without clinical symptoms or with clinical symptoms controlled and stabilized for ≥4 weeks after treatment：
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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 throughout the trial period and for 7 months after the final study dose;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Hao Zhuang, M.D., 18603731088, zhh8764@163.com
About this study
Official title: A Single-Arm, Prospective, Open Clinical Study of Palbociclib for Backline Treatment of Advanced Hepatocellular Carcinoma
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Palbociclib capsules
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib capsulesDrug
Also called Palbociclib
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.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib Group | Experimental | Palbociclib capsules, oral, qd Receives: Drug: Palbociclib capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to approximately 2 years.
Secondary outcomes (4)
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.
Measured: up to approximately 2 years.
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).
Measured: up to approximately 2 years.
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: up to approximately 2 years.
Adverse Events (AE)
AE assessed by NCI-CTCAE V5.0.
Measured: up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start15 Jan 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Palbociclib Capsules
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hao Zhuang, M.D., Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478927
- Sponsor's protocol ID
- HN-HCC-Palbociclib-001
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Open Clinical Study of Palbociclib for Backline Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06478927
- Acronym / sponsor ID
- HN-HCC-Palbociclib-001
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Palbociclib Capsules
| Arm | Type | Receives |
|---|---|---|
| Palbociclib Group | Experimental | Drug: Palbociclib capsulesPalbociclib capsules, oral, qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palbociclib capsulesAlso: PalbociclibPalbociclib 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. | Drug | Palbociclib Group |
Primary outcome
Progression-free survival (PFS)
Time frame: up to approximately 2 years.
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.
4 secondary outcomes
Objective response rate (ORR)
Time frame: up to approximately 2 years.
Disease control rate (DCR)
Time frame: up to approximately 2 years.
Overall survival (OS)
Time frame: up to approximately 2 years.
Adverse Events (AE)
Time frame: up to approximately 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao Zhuang, M.D. principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palbociclib capsules in people with Hepatocellular Carcinoma, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhuang, M.D. (18603731088, zhh8764@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to approximately 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.