Unresectable Hepatocellular CarcinomaPhase 3NCT05263219
DEB-TACE+HAIC vs. HAIC for Large HCC
A Phase 3 study testing dTACE-HAIC, HAIC and dTACE-HAIC protocol in people with Unresectable Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone for unresectable large hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- dTACE-HAIC, HAIC and dTACE-HAIC protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 9 Feb 2026
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HCC confirmed by histology/cytology or diagnosed clinically.
- The maximum HCC lesion > 7 cm.
- Unresectable HCC evaluated by the surgeon team.
- At least one measurable intrahepatic target lesion.
- Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
- ECOG score of performance status ≤ 1 point.
- Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.
- Life expectancy of at least 3 months.
Who cannot join
- Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.
- Accompanied with vena cava tumor thrombus.
- Extrahepatic metastasis.
- Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment.
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- History of other malignancies.
- Uncontrollable infection.
- History of HIV.
- Allergic to the drugs involved in the research.
- Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.
- History of organ or cells transplantation.
- Those with bleeding tendency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
About this study
Official title: Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone for unresectable large hepatocellular carcinoma (HCC).
Read the detailed description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of DEB-TACE (with CalliSpheres) plus HAIC compared with HAIC alone for unresectable large HCC (>7cm).
230 patients with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE plus HAIC (dTACE-HAIC) or HAIC as the primary treatment using an 1:1 randomization scheme. In the dTACE-HAIC arm, the microcatheter will be reserved at the proper/left/right hepatic artery and chemotherapy drugs (FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. The treatment can be repeated on demand (at a 4-6-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the HAIC arm, treatment will repeated once every 3 weeks for up to six cycles. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is overall survival (OS). The secondary endpoints are tumor response (objective response rate and disease control rate), success rate of conversion to resection, progression-free survival (PFS), and adverse events (AEs).
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- dTACE-HAIC, HAIC, dTACE-HAIC protocol, HAIC protocol
- Keywords
- Hepatocellular Carcinoma, Transarterial chemoembolization, Hepatic arterial infusion chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dTACE-HAICProcedure or surgery
For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
After each chemoembolization, the microcatheter is reserved at the proper/left/right hepatic artery. The FOLFOX-based regimen is intra-arterially administered.
During follow-up, the treatment will be repeated on demand (at a 4-6-week interval usually) based on the evaluation of the follow-up laboratory and imaging examination.
HAICProcedure or surgery
HAIC treatment is divided into 3-week cycles. The microcatheter is advanced into the proper/left/right hepatic artery on day 1 in every cycle of treatment. After the patient returned to the ward, the FOLFOX-based regimen is intra-arterially administered though the microcatheter.
The treatment is repeated once every 3 weeks for up to six cycles.
dTACE-HAIC protocolDrug
Also called Drugs for DEB-TACE and HAIC
CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.
FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.
HAIC protocolDrug
Also called Drugs for HAIC
FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.
| Study group | Role | What they receive |
|---|---|---|
| Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy | Experimental | Patients will receive the combination treatment of DEB-TACE and HAIC. Receives: Procedure: dTACE-HAIC; Drug: dTACE-HAIC protocol |
| Hepatic arterial infusion chemotherapy | Active comparator | Patients will receive HAIC treatment alone. Receives: Procedure: HAIC; Drug: HAIC protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from date of randomization to death due to any cause.
Measured: 4 years.
Secondary outcomes (8)
Objective response rate (ORR) per mRECIST.
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.
Measured: 4 years.
ORR per RECIST 1.1.
The proportion of patients with the best response of CR or PR according to RECIST 1.1.
Measured: 4 years.
Disease control rate (DCR) per mRECIST.
The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.
Measured: 4 years.
DCR per RECIST 1.1.
The proportion of patients with the best response of CR, PR, or SD according to RECIST 1.1.
Measured: 4 years.
Progression free survival (PFS) per mRECIST.
The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: 4 years.
Progression free survival (PFS) per RECIST 1.1.
The time from date of randomization until the first occurrence of disease progression (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: 4 years.
Success rate of conversion to resection
The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for surgical resection after dTACE-HAIC or HAIC treatment.
Measured: 4 years.
Adverse Events (AEs)
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Measured: 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start10 Feb 2022
- Primary completion9 Feb 2026 (estimated)
- Study completion9 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hainan General Hospital, Maoming People's Hospital, Zhongshan People's Hospital, Guangdong, China, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan, Jiangmen Central Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Kangshun Zhu, Dr., Study chair, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263219
- Sponsor's protocol ID
- MIIR-09
- Status last verified
- Jun 2023
- First submitted
- 12 Feb 2022
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05263219
- Acronym / sponsor ID
- MIIR-09
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Transarterial chemoembolization, Hepatic arterial infusion chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Hainan General Hospital, Maoming People's Hospital, Zhongshan People's Hospital, Guangdong, China, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan, Jiangmen Central Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 9 Feb 2026 (estimated)
- Study completion
- 9 Feb 2026 (estimated)
- First posted
- 2 Mar 2022 (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 is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone for unresectable large hepatocellular carcinoma (HCC).
Detailed description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of DEB-TACE (with CalliSpheres) plus HAIC compared with HAIC alone for unresectable large HCC (>7cm).
230 patients with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE plus HAIC (dTACE-HAIC) or HAIC as the primary treatment using an 1:1 randomization scheme. In the dTACE-HAIC arm, the microcatheter will be reserved at the proper/left/right hepatic artery and chemotherapy drugs (FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. The treatment can be repeated on demand (at a 4-6-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the HAIC arm, treatment will repeated once every 3 weeks for up to six cycles. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is overall survival (OS). The secondary endpoints are tumor response (objective response rate and disease control rate), success rate of conversion to resection, progression-free survival (PFS), and adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy | Experimental | Procedure: dTACE-HAIC, Drug: dTACE-HAIC protocolPatients will receive the combination treatment of DEB-TACE and HAIC. |
| Hepatic arterial infusion chemotherapy | Active comparator | Procedure: HAIC, Drug: HAIC protocolPatients will receive HAIC treatment alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with HCC confirmed by histology/cytology or diagnosed clinically.
- The maximum HCC lesion > 7 cm.
- Unresectable HCC evaluated by the surgeon team.
- At least one measurable intrahepatic target lesion.
- Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
Key exclusion criteria (13 listed)
- Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.
- Accompanied with vena cava tumor thrombus.
- Extrahepatic metastasis.
- Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and 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 |
|---|---|---|
| dTACE-HAICFor DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the proper/left/right hepatic artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment will be repeated on demand (at a 4-6-week interval usually) based on the evaluation of the follow-up laboratory and imaging examination. | Procedure or surgery | Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy |
| HAICHAIC treatment is divided into 3-week cycles. The microcatheter is advanced into the proper/left/right hepatic artery on day 1 in every cycle of treatment. After the patient returned to the ward, the FOLFOX-based regimen is intra-arterially administered though the microcatheter. The treatment is repeated once every 3 weeks for up to six cycles. | Procedure or surgery | Hepatic arterial infusion chemotherapy |
| dTACE-HAIC protocolAlso: Drugs for DEB-TACE and HAICCalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected. FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h. | Drug | Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy |
| HAIC protocolAlso: Drugs for HAICFOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h. | Drug | Hepatic arterial infusion chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: 4 years.
The time from date of randomization to death due to any cause.
8 secondary outcomes
Objective response rate (ORR) per mRECIST.
Time frame: 4 years.
ORR per RECIST 1.1.
Time frame: 4 years.
Disease control rate (DCR) per mRECIST.
Time frame: 4 years.
DCR per RECIST 1.1.
Time frame: 4 years.
Progression free survival (PFS) per mRECIST.
Time frame: 4 years.
Progression free survival (PFS) per RECIST 1.1.
Time frame: 4 years.
Success rate of conversion to resection
Time frame: 4 years.
Adverse Events (AEs)
Time frame: 4 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
Kangshun Zhu, Dr. study chair
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dTACE-HAIC, HAIC and dTACE-HAIC protocol in people with Unresectable Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingyue Cai, Dr. (+86-20-34156205, cai020@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 4 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 22 Jun 2023; AzTrials last refreshed its copy on 29 Oct 2026.