Hepatocellular CarcinomaNCT06641713
HAIC Compared With TACE in Huge Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Hepatic Chemotherapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer
- What is being tested?
- TACE and HAIC
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 664 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Dec 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: This study is a multicenter, observational real-world study to compare the efficacy of HAIC with TACE in advancedhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy . This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC and TACE in huge HCC therapy.
Who may be able to join
- Clinical diagnosis of primary HCC.
- Age between 18 and 75 years;
- The maximum tumor size ≥10 cm;
- Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
- limited metastases (≤5).
- Child-Pugh class A or B;
Show all 9Show fewer
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
- Prothrombin time ≤18s or international normalized ratio < 1.7.
Who cannot join
- recurrent HCC;
- Extrahepatic metastasis >5;
- Obstructive PVTT involving mesenteric vena cava (PVTT IV).
- Serious medical comorbidities.
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Eastern Cooperative Group performance status (ECOG) score of ≥2;
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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
Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Qunfang Zhou, MD, 8619868000115, zhouqun988509@163.com
Feng Duan, MD, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study
This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.
Read the detailed description
Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.
- Conditions
- Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer
- Being tested
- TACE, HAIC
- Keywords
- Advanced hepatocellular carcinoma, TACE, HAIC, system therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels.
HAICProcedure or surgery
HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| TACE | TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then conventional TACE or drug-eluting TACE was used. Receives: Procedure: TACE | |
| HAIC | HIAC was conducted with hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 3-4 weeks. Receives: Procedure: HAIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
Measured: 6 months
Secondary outcomes (2)
Progression-Free-Survival
Progression was defined as progressive disease by independent radiologic review
Measured: 12 months
Overall survival
OS is the length of time from the date of inclusion until death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (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 Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 664 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, MD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641713
- Sponsor's protocol ID
- Liver Projiect 13
- Status last verified
- Mar 2025
- First submitted
- 12 Oct 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06641713
- Acronym / sponsor ID
- Liver Projiect 13
- Conditions
- Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer
- Keywords
- Advanced hepatocellular carcinoma, TACE, HAIC, system therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 664 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 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.
This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.
Detailed description
Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE | – | Procedure: TACETACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then conventional TACE or drug-eluting TACE was used. |
| HAIC | – | Procedure: HAICHIAC was conducted with hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 3-4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study is a multicenter, observational real-world study to compare the efficacy of HAIC with TACE in advancedhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy . This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC and TACE in huge HCC therapy.
Key inclusion criteria (9 listed)
- Clinical diagnosis of primary HCC.
- Age between 18 and 75 years;
- The maximum tumor size ≥10 cm;
- Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
- limited metastases (≤5).
Key exclusion criteria (8 listed)
- recurrent HCC;
- Extrahepatic metastasis >5;
- Obstructive PVTT involving mesenteric vena cava (PVTT IV).
- Serious medical comorbidities.
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
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 |
|---|---|---|
| TACETACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels. | Procedure or surgery | TACE |
| HAICHAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks | Procedure or surgery | HAIC |
Primary outcome
Objective response rate
Time frame: 6 months
ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
2 secondary outcomes
Progression-Free-Survival
Time frame: 12 months
Overall survival
Time frame: 24 months
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 26 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.
Feng Duan, MD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Hepatic Chemotherapy, run by Sun Yat-sen University 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 9 inclusion and 8 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 26 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 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 Qunfang Zhou, MD (86 19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 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 26 Mar 2025.