Hepatocellular Carcinoma (HCC)Phase 1/2NCT05770882
Chidamide + Regorafenib in Hepatocellular Carcinoma (HCC)
A Phase 1/2 study testing Chidamide and Regorafenib in people with Hepatocellular Carcinoma (HCC), run by Great Novel Therapeutics Biotech & Medicals Corporation at 5 sites in Taiwan.
Trial summary
This open-label, phase Ib/II, multicenter study evaluated the safety, tolerability, efficacy, and PK of chidamide in combination with regorafenib in patients with HCC. Chidamide, a histone deacetylase inhibitor, functions as a tumor inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Chidamide and Regorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesTaiwan
- Study dates
- 25 Apr 2023to 17 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
- Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation, chemoembolization or first-line systemic therapy.
- Has received and failed one front-line systemic treatment with either sorafenib, lenvatinib, or combination of PD-1/PD-L1 immune checkpoint inhibitor (ICI; anti-PD-1/PD-L1 mAb) plus bevacizumab, lenvatinib or anti-CTLA-4 mAb.
- Tolerability of prior treatment with sorafenib or lenvatinib. Tolerability to previous sorafenib treatment is defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal. Tolerability to previous lenvatinib treatment is defined as not less than 20 days at a daily dose of 8 mg QD for patients ≥60 kg or 4 mg QD for patients <60 kg days within the last 28 days prior to withdrawal.
- Liver function status Child-Pugh Class A. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
- Local or loco-regional therapy of intrahepatic tumor lesions (e.g., surgery, radiation therapy, hepatic arterial embolization or infusion chemotherapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks before the first dose of study medication.
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- ECOG PS of 0 or 1.
- With adequate bone marrow, liver, and renal functions, as assessed by the following laboratory tests conducted within 7 days before the first dose of study medication:
- At least one uni-dimensional measurable lesion by computed tomography scan or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST for HCC (mRECIST). Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
- With a life expectancy of at least 3 months.
- Females of childbearing potential and males must agree to use adequate contraception since signing of the informed consent form until at least 2 months after the last study drug administration.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test.
- Able to take oral medication.
- Has ability to understand and the willingness to provide a written informed consent document.
Who cannot join
- With history of organ transplantation or candidates for liver transplantation.
- Prior treatment with regorafenib.
- First-line treatment within 4 weeks before the first dose of study medication.
- Permanent discontinuation of prior sorafenib or lenvatinib therapy due to drug-related toxicity.
- Known history or symptomatic metastatic brain or meningeal tumors. Note: If patients showed symptomatic brain metastases at screening, magnetic resonance imaging (MRI) or computed tomography (CT) scanning should be performed to demonstrate any current evidence of progressive brain metastases.
- Major surgical procedure or significant traumatic injury within 28 days before the first dose of study medication.
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- With uncontrolled or significant cardiovascular diseases
- With the size of fluid area detected by cardiac ultrasonography in cavum pericardium ≥ 10 mm.
- Patients with pheochromocytoma.
- Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis treatment).
- Pleural effusion or ascites that causes respiratory compromise (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 grade ≥2 dyspnea).
- Ongoing infection grade >2 according to NCI-CTCAE v5.0. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.
- Clinically significant bleeding NCI-CTCAE v5.0 grade ≥3 within 30 days before the first dose of study medication.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the first dose of study medication..
- With autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
- Non-healing wound, ulcer, or bone fracture.
- Renal failure requiring hemo- or peritoneal dialysis.
- Interstitial lung disease with ongoing signs and symptoms at the time of screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan
About this study
Official title: A Phase Ib/II, Two-part, Non-randomized, Open-label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Chidamide in Combination With Regorafenib in Patients With Hepatocellular Carcinoma
This open-label, phase Ib/II, multicenter study evaluated the safety, tolerability, efficacy, and PK of chidamide in combination with regorafenib in patients with HCC. Chidamide, a histone deacetylase inhibitor, functions as a tumor inhibitor. Regorafenib, a receptor tyrosine kinase inhibitor, was approved as second-line systemic treatment for HCC patients.
Read the detailed description
This is an open-label, multicenter, phase Ib/II study, which includes a Part I (phase Ib) and a Cohort Expansion part (Part II; phase II). Part I of the study is designed to assess the safety, tolerability, PK profiles, efficacy, and PD biomarkers of the study medications in patients with HCC. Part II of the study is designed to assess the efficacy, safety, and PD biomarkers.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Chidamide, Regorafenib
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called Tucidinostat, HBI-8000
Subjects will receive a single dose of chidamide. 5mg tablet. One dose every three days.
RegorafenibDrug
Also called Stivarga, BAY 73-4506
Subjects will receive a single dose of Regorafenib. 40mg tablet. One dose daily.
| Study group | Role | What they receive |
|---|---|---|
| Part I safety; and Part II cohort expansion | Experimental | Part I: The safety of drug combination will be studied.
Part II: The drug combination will be further evaluated in the cohort expansion phase. Receives: Drug: Chidamide; Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE)
To analyze the frequency, percentage of patients with study medications of adverse events
Measured: From the first day of treatment until progressive disease or death, assessed up to 12 months
Maximum tolerated dose(MTD) / maximum feasible dose (MFD)
To assess tolerability/feasible of study medications dose
Measured: From start of treatment Cycle1 Day1 until completion of one cycle of treatment (maximum 28 days)
Pharmacokinetics profiles - (AUC0-t)
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Measured: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (AUC0-∞)
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Measured: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Cmax)
Maximum plasma concentration(Cmax)
Measured: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Tmax)
Time to maximum plasma concentration(Tmax)
Measured: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (T1/2)
Half-life(T1/2)
Measured: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Objective response rate (ORR)
The percentage of patients with CR and PR of total number of analysis set
Measured: Objective Response Rate is assessed every 8 weeks from start of treatment until progressive disease is documented (approximately 6 months)
Progression-free survival (PFS)
The time from first day of dosing until the date of first objective disease progression or death
Measured: From the first day of treatment until disease progression or death from any cause, assessed up to 12 months
Secondary outcomes (2)
Overall survival (OS)
The time from the first day of dosing until the date of death
Measured: 1 year
Time to progression (TTP)
The time from the first day of dosing until the date of progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start25 Apr 2023
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Why it stopped: The overall profile does not support development for Hepatocellular Carcinoma
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Novel Therapeutics Biotech & Medicals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Nan Chen, Ph.D., Study director, Great Novel Therapeutics Biotech & Medicals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770882
- Sponsor's protocol ID
- KEPIDA-1
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Two-part, Non-randomized, Open-label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Chidamide in Combination With Regorafenib in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05770882
- Acronym / sponsor ID
- KEPIDA-1
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The overall profile does not support development for Hepatocellular Carcinoma
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Great Novel Therapeutics Biotech & Medicals CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 16 Mar 2023 (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.
This open-label, phase Ib/II, multicenter study evaluated the safety, tolerability, efficacy, and PK of chidamide in combination with regorafenib in patients with HCC. Chidamide, a histone deacetylase inhibitor, functions as a tumor inhibitor. Regorafenib, a receptor tyrosine kinase inhibitor, was approved as second-line systemic treatment for HCC patients.
Detailed description
This is an open-label, multicenter, phase Ib/II study, which includes a Part I (phase Ib) and a Cohort Expansion part (Part II; phase II). Part I of the study is designed to assess the safety, tolerability, PK profiles, efficacy, and PD biomarkers of the study medications in patients with HCC. Part II of the study is designed to assess the efficacy, safety, and PD biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part I safety; and Part II cohort expansion | Experimental | Drug: Chidamide, Drug: RegorafenibPart I: The safety of drug combination will be studied. Part II: The drug combination will be further evaluated in the cohort expansion phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
- Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation, chemoembolization or first-line systemic therapy.
- Has received and failed one front-line systemic treatment with either sorafenib, lenvatinib, or combination of PD-1/PD-L1 immune checkpoint inhibitor (ICI; anti-PD-1/PD-L1 mAb) plus bevacizumab, lenvatinib or anti-CTLA-4 mAb.
- Tolerability of prior treatment with sorafenib or lenvatinib. Tolerability to previous sorafenib treatment is defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal. Tolerability to previous lenvatinib treatment is defined as not less than 20 days at a daily dose of 8 mg QD for patients ≥60 kg or 4 mg QD for patients <60 kg days within the last 28 days prior to withdrawal.
- Liver function status Child-Pugh Class A. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
Key exclusion criteria (18 listed)
- With history of organ transplantation or candidates for liver transplantation.
- Prior treatment with regorafenib.
- First-line treatment within 4 weeks before the first dose of study medication.
- Permanent discontinuation of prior sorafenib or lenvatinib therapy due to drug-related toxicity.
- Known history or symptomatic metastatic brain or meningeal tumors. Note: If patients showed symptomatic brain metastases at screening, magnetic resonance imaging (MRI) or computed tomography (CT) scanning should be performed to demonstrate any current evidence of progressive brain metastases.
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 |
|---|---|---|
| ChidamideAlso: Tucidinostat, HBI-8000Subjects will receive a single dose of chidamide. 5mg tablet. One dose every three days. | Drug | Part I safety; and Part II cohort expansion |
| RegorafenibAlso: Stivarga, BAY 73-4506Subjects will receive a single dose of Regorafenib. 40mg tablet. One dose daily. | Drug | Part I safety; and Part II cohort expansion |
Primary outcome
Adverse event (AE)
Time frame: From the first day of treatment until progressive disease or death, assessed up to 12 months
To analyze the frequency, percentage of patients with study medications of adverse events
Maximum tolerated dose(MTD) / maximum feasible dose (MFD)
Time frame: From start of treatment Cycle1 Day1 until completion of one cycle of treatment (maximum 28 days)
To assess tolerability/feasible of study medications dose
Pharmacokinetics profiles - (AUC0-t)
Time frame: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Pharmacokinetics profiles - (AUC0-∞)
Time frame: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Pharmacokinetics profiles - (Cmax)
Time frame: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Maximum plasma concentration(Cmax)
Pharmacokinetics profiles - (Tmax)
Time frame: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Time to maximum plasma concentration(Tmax)
Pharmacokinetics profiles - (T1/2)
Time frame: Blood samples collected on Days 1-4 and 18-21 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Half-life(T1/2)
Objective response rate (ORR)
Time frame: Objective Response Rate is assessed every 8 weeks from start of treatment until progressive disease is documented (approximately 6 months)
The percentage of patients with CR and PR of total number of analysis set
Progression-free survival (PFS)
Time frame: From the first day of treatment until disease progression or death from any cause, assessed up to 12 months
The time from first day of dosing until the date of first objective disease progression or death
2 secondary outcomes
Overall survival (OS)
Time frame: 1 year
Time to progression (TTP)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The overall profile does not support development for Hepatocellular Carcinoma). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Chia-Nan Chen, Ph.D. study director
Great Novel Therapeutics Biotech & Medicals Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chidamide and Regorafenib in people with Hepatocellular Carcinoma (HCC), run by Great Novel Therapeutics Biotech & Medicals Corporation at 5 sites in Taiwan.
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 14 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The overall profile does not support development for Hepatocellular Carcinoma). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (AE) (time frame: From the first day of treatment until progressive disease or death, assessed up to 12 months). The study lists 9 primary outcomes in all. 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 11 Mar 2025.