Hepatocellular CarcinomaPhase 2NCT06632717
Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma
A Phase 2 study testing Cisplatin, 5-fluorouracil and Lipiodol embolization in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hepatic artery infusion chemotherapy (HAIC) is a locoregional therapy commonly used in hepatocellular carcinoma (HCC), with high response rates and minimal impairment of liver function reported. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cisplatin, 5-fluorouracil and Lipiodol embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2024to 1 Jun 2027
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Histologically or clinically (typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease (liver confined disease or liver predominant disease, as determined by the investigator) or BCLC Stage B disease who failed standard treatment (i.e., TACE in intermediate stage HCC or systemic therapy in advanced HCC) or refused standard treatment or intolerable to standard treatment.
- Archival tissue available (< 2 years) or agree to have biopsy tissue at baseline
- Age > 20 years at the time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Child-Pugh class A or B7
- ≥1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the liver
- Body weight >30 kg
- Adequate normal organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL (2) Absolute neutrophil count (ANC) ≥1.0 x 109/L (≥ 1,000 per mm3) (3) Platelet count ≥75 x 109/L (≥75,000 per mm3) (4) Serum bilirubin ≤2 x institutional upper limit of normal (ULN). (5) AST (SGOT)/ALT (SGPT) ≤3x institutional upper limit of normal unless active liver malignancies are present, in which case it must be ≤5x ULN (6) Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: 11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- 12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- 13. Must have a life expectancy of at least 12 weeks
Who cannot join
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- The result of lung perfusion scan of the HAIC port > 30%
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤14 days prior to the first dose of the study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by the principal investigator.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
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- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (except HBV infection or HCV infection), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another primary malignancy except for conditions listed in the protocol.
- History of leptomeningeal carcinomatosis
- Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
- History of active primary immunodeficiency
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of the trial treatment.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Tsung-Hao Liu, MD, +886223123456, thliu@ntuh.gov.tw
About this study
Official title: Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy With Cisplatin and Fluorouracil in Combination With Lipiodol Embolization in Advanced Hepatocellular Carcinoma - a Prospective, Single-arm, Phase 2 Pilot Study
Hepatic artery infusion chemotherapy (HAIC) is a locoregional therapy commonly used in hepatocellular carcinoma (HCC), with high response rates and minimal impairment of liver function reported. Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are also commonly used in HCC, with high response rates reported yet carry risks of impairing liver function after repeated embolization with a definitive embolic agent. On the other hand, lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the definitive embolic agent. This study investigates whether combining HAIC with lipiodol embolization will increase efficacy with good liver function preservation.
Read the detailed description
Hepatic artery infusion chemotherapy (HAIC) is an effective locoregional therapy commonly utilized in hepatocellular carcinoma (HCC). The rationale for the anti-tumor efficacy of HAIC is to deliver high local concentrations of chemotherapeutic agents to the liver tumor. Previous studies on HAIC alone or in combination with other systemic therapies have demonstrated excellent intrahepatic tumor contr rates and survival benefits. The investigators have previously conducted a pilot study of HAIC in National Taiwan University Hospital (NTUH) using cisplatin and 5-fluorouracil and demonstrated a high response rate of 26% in advanced HCC patients. In addition to the observed efficacy, HAIC does not impair liver function significantly over repeated administration and can be safely given to patients with poor or limited liver reserve.
Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are the most recognized standard treatment in intermediate-stage HCC and are also commonly utilized in advanced-stage HCC. TACE procedure is based on administering a cytotoxic drug mixed with lipiodol followed by definitive embolization of the tumor-feeding arteries by an embolic agent. However, repeated embolization can impair liver function and jeopardize the chance of patients receiving further salvage treatment. Lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the embolic agent, such as Gelfoam. Performing embolization with lipiodol alone without an embolic agent may limit detrimental effects on the normal liver and help preserve liver function in patients with HCC.
The investigators hypothesize that combining HAIC and transient embolization using lipiodol may have enhanced efficacy compared to HAIC alone. In addition, the unwanted liver function impairment caused by repeated embolization is alleviated by the characteristic transient embolization effect of lipiodol. Thus, The investigators propose this prospective, single-arm, phase 2 pilot study comprising HAIC with cisplatin and 5-fluorouracil in combination with lipiodol embolization to investigate its efficacy and safety in patients with advanced HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cisplatin, 5-fluorouracil, Lipiodol embolization
- Keywords
- Hepatic Arterial Infusional Chemotherapy, Lipiodol Embolization, Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Chemotherapy regimen
- Cisplatin 60mg/m2 on day 2; 5-fluorouracil (5-FU) 500mg/m2 on day 1 - day 3 via the HAIC port, every 3 weeks until progression or intolerable toxicity
5-fluorouracilDrug
Also called 5-FU
Chemotherapy regimen
- Cisplatin 60mg/m2 on day 2; 5-fluorouracil (5-FU) 500mg/m2 on day 1 - day 3 via the HAIC port, every 3 weeks until progression or intolerable toxicity
Lipiodol embolizationProcedure or surgery
Also called ethiodized oil
Lipiodol embolization protocol
- Lipiodol embolization will be performed on day 3 after completion of 5-FU infusion, up to 4 cycles. Fixed dose lipiodol of 10mL will be given on day 3 followed by 30mL normal saline flush.
- The administration of lipiodol is mandatory on cycle 1. The administration of lipiodol on cycle 2 to cycle 4 will depend on the discretion of the treating physician and the presence of adverse effects from lipiodol embolization.
| Study group | Role | What they receive |
|---|---|---|
| HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization | Experimental | hepatic arterial infusional cisplatin and 5-fluorouracil will be given followed by lipiodol embolization Receives: Drug: Cisplatin; Drug: 5-fluorouracil; Procedure: Lipiodol embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (RECIST 1.1)
To assess the objective response rate (RECIST 1.1) of HAIC-PF + lipiodol embolization.
Measured: From date of randomization until the date of first documented confirmed response rate by RECIST 1.1, assessed up to 60 months
Secondary outcomes (5)
Objective response rate (mRECIST)
To assess the objective response rate (modified RECIST) of HAIC-PF + lipiodol embolization
Measured: From date of randomization until the date of first documented confirmed response rate by mRECIST, assessed up to 60 months
Liver specific objective response rate (RECIST 1.1 & modified RECIST)
To assess the liver specific objective response rate (RECIST 1.1 \& modified RECIST) of HAIC-PF + lipiodol embolization.
Measured: From date of randomization until the date of first documented liver specific confirmed response rate by RECIST 1.1 & mRECIST, assessed up to 60 months
Progression-free survival (RECIST 1.1 and modified RECIST)
To assess the progression-free survival (RECIST 1.1 or modified RECIST) of HAIC-PF + lipiodol embolization
Measured: From date of randomization until the date of first documented progression (RECIST 1.1 or mRECIST) or date of death from any cause, whichever came first, assessed up to 60months
Overall survival
To assess the overall survival of HAIC-PF + lipiodol embolization
Measured: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 60 months
Incidence of treatment-emergent adverse events [safety and tolerability]
To assess the incidence of treatment-emergent adverse events of HAIC-PF + lipiodol embolization by reporting number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From date of randomization until 3 months after the end-of-trial, assessed up to 60months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Sep 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Jun 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 National Taiwan University 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung-Hao Liu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632717
- Sponsor's protocol ID
- 202311007MINA
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy With Cisplatin and Fluorouracil in Combination With Lipiodol Embolization in Advanced Hepatocellular Carcinoma - a Prospective, Single-arm, Phase 2 Pilot Study
- ClinicalTrials.gov ID
- NCT06632717
- Acronym / sponsor ID
- 202311007MINA
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatic Arterial Infusional Chemotherapy, Lipiodol Embolization, Hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Oct 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.
Hepatic artery infusion chemotherapy (HAIC) is a locoregional therapy commonly used in hepatocellular carcinoma (HCC), with high response rates and minimal impairment of liver function reported. Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are also commonly used in HCC, with high response rates reported yet carry risks of impairing liver function after repeated embolization with a definitive embolic agent. On the other hand, lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the definitive embolic agent. This study investigates whether combining HAIC with lipiodol embolization will increase efficacy with good liver function preservation.
Detailed description
Hepatic artery infusion chemotherapy (HAIC) is an effective locoregional therapy commonly utilized in hepatocellular carcinoma (HCC). The rationale for the anti-tumor efficacy of HAIC is to deliver high local concentrations of chemotherapeutic agents to the liver tumor. Previous studies on HAIC alone or in combination with other systemic therapies have demonstrated excellent intrahepatic tumor contr rates and survival benefits. The investigators have previously conducted a pilot study of HAIC in National Taiwan University Hospital (NTUH) using cisplatin and 5-fluorouracil and demonstrated a high response rate of 26% in advanced HCC patients. In addition to the observed efficacy, HAIC does not impair liver function significantly over repeated administration and can be safely given to patients with poor or limited liver reserve.
Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are the most recognized standard treatment in intermediate-stage HCC and are also commonly utilized in advanced-stage HCC. TACE procedure is based on administering a cytotoxic drug mixed with lipiodol followed by definitive embolization of the tumor-feeding arteries by an embolic agent. However, repeated embolization can impair liver function and jeopardize the chance of patients receiving further salvage treatment. Lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the embolic agent, such as Gelfoam. Performing embolization with lipiodol alone without an embolic agent may limit detrimental effects on the normal liver and help preserve liver function in patients with HCC.
The investigators hypothesize that combining HAIC and transient embolization using lipiodol may have enhanced efficacy compared to HAIC alone. In addition, the unwanted liver function impairment caused by repeated embolization is alleviated by the characteristic transient embolization effect of lipiodol. Thus, The investigators propose this prospective, single-arm, phase 2 pilot study comprising HAIC with cisplatin and 5-fluorouracil in combination with lipiodol embolization to investigate its efficacy and safety in patients with advanced HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization | Experimental | Drug: Cisplatin, Drug: 5-fluorouracil, Procedure: Lipiodol embolizationhepatic arterial infusional cisplatin and 5-fluorouracil will be given followed by lipiodol embolization |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Histologically or clinically (typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease (liver confined disease or liver predominant disease, as determined by the investigator) or BCLC Stage B disease who failed standard treatment (i.e., TACE in intermediate stage HCC or systemic therapy in advanced HCC) or refused standard treatment or intolerable to standard treatment.
- Archival tissue available (< 2 years) or agree to have biopsy tissue at baseline
- Age > 20 years at the time of study entry.
Key exclusion criteria (15 listed)
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- The result of lung perfusion scan of the HAIC port > 30%
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤14 days prior to the first dose of the study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by the principal investigator.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
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 |
|---|---|---|
| CisplatinChemotherapy regimen • Cisplatin 60mg/m2 on day 2; 5-fluorouracil (5-FU) 500mg/m2 on day 1 - day 3 via the HAIC port, every 3 weeks until progression or intolerable toxicity | Drug | HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization |
| 5-fluorouracilAlso: 5-FUChemotherapy regimen • Cisplatin 60mg/m2 on day 2; 5-fluorouracil (5-FU) 500mg/m2 on day 1 - day 3 via the HAIC port, every 3 weeks until progression or intolerable toxicity | Drug | HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization |
| Lipiodol embolizationAlso: ethiodized oilLipiodol embolization protocol * Lipiodol embolization will be performed on day 3 after completion of 5-FU infusion, up to 4 cycles. Fixed dose lipiodol of 10mL will be given on day 3 followed by 30mL normal saline flush. * The administration of lipiodol is mandatory on cycle 1. The administration of lipiodol on cycle 2 to cycle 4 will depend on the discretion of the treating physician and the presence of adverse effects from lipiodol embolization. | Procedure or surgery | HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization |
Primary outcome
Objective response rate (RECIST 1.1)
Time frame: From date of randomization until the date of first documented confirmed response rate by RECIST 1.1, assessed up to 60 months
To assess the objective response rate (RECIST 1.1) of HAIC-PF + lipiodol embolization.
5 secondary outcomes
Objective response rate (mRECIST)
Time frame: From date of randomization until the date of first documented confirmed response rate by mRECIST, assessed up to 60 months
Liver specific objective response rate (RECIST 1.1 & modified RECIST)
Time frame: From date of randomization until the date of first documented liver specific confirmed response rate by RECIST 1.1 & mRECIST, assessed up to 60 months
Progression-free survival (RECIST 1.1 and modified RECIST)
Time frame: From date of randomization until the date of first documented progression (RECIST 1.1 or mRECIST) or date of death from any cause, whichever came first, assessed up to 60months
Overall survival
Time frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 60 months
Incidence of treatment-emergent adverse events [safety and tolerability]
Time frame: From date of randomization until 3 months after the end-of-trial, assessed up to 60months
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 25 Nov 2025.
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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.
Tsung-Hao Liu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, 5-fluorouracil and Lipiodol embolization in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site 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 13 inclusion and 15 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 25 Nov 2025. 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 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 phase mean?
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?
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 Tsung-Hao Liu, MD (+88623123456 ext. 66006, thliu@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (RECIST 1.1) (time frame: From date of randomization until the date of first documented confirmed response rate by RECIST 1.1, assessed up to 60 months). 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 25 Nov 2025.