HCCNCT05788835
DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial
A study testing DEB-TACE and HAIC and DEB-TACE in people with HCC, run by Xuhua Duan at 16 sites in China.
Trial summary
This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- DEB-TACE and HAIC and DEB-TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 16 sitesChina
- Study dates
- 7 Mar 2023to 30 Jun 2026
- Phase
- Interventional
- 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
- Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).
- The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.
- Patient age between 18 and 75，male or female.
- ECOG 0-1.
- Expected life span ≥ 3 months.
- No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
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- Child-Pugh A-B.
- HBV DNA<2000 IU/ml.
- Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
- Patients sign informed consent, good compliance, cooperate with treatment.
Who cannot join
- Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.
- Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
- Diffuse liver cancer patients.
- Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
- A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
- Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
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- Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.
- Systemic failure, estimated survival time <3 months.
- Severe renal dysfunction.
- The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Second People's Hospital of Jiaozuo
Jiaozuo
Chuntang Qin
- Recruiting
Luo He Central Hospital
Luohe, Henan
Yaoxian Liu
- Recruiting
Luo Yang Central Hospital
Luoyang, Henan
Fazhong Li
- Recruiting
Deng zhou People's Hospital
Nanyang, Henan
Yanliang Li
- Recruiting
Nan Yang Central Hospital
Nanyang, Henan
Yangao Ma
- Recruiting
General Hospital of Pingmei Shenma Group
Pingdingshan, Henan
Peixin Zhu
- Recruiting
First People's Hospital of Shangqiu
Shangqiu, Henan
Limin Xie
- Recruiting
Shangqiu Municipal Hospital
Shangqiu, Henan
Baoning Guo
- Recruiting
Xin Yang Central Hospital
Xinyang, Henan
Kun Du
- Recruiting
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Jun Lv
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xuhua Duan, +8613523402912, xuhuaduan@163.com
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan
Haibo Wang
- Recruiting
Zhou Kou Central Hospital
Zhoukou, Henan
Cheng Xing
- Recruiting
First People's Hospital of Zhu Madian
Zhumadian, Henan
Lin Wei
- Recruiting
Zhu Ma Dian Central Hospital
Zhumadian, Henan
Hui Yu
- Recruiting
Zhu Madian Traditional Chinese Medicine Hospital
Zhumadian, Henan
Shutang Yuan
About this study
Official title: Drug-eluting Bead Transarterial Chemoembolization and Drug-eluting Bead Transarterial Chemoembolization Sequential Hepatic Artery Chemotherapy Infusion for Unresectable BCLC Stage C HCC: A Randomized Controlled Trial
This is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC
Read the detailed description
Primary liver cancer is one of the most common malignant tumors in the world. According to the survey results of the BRIDGE study, about 64% of Chinese patients with liver cancer had BCLC stage B and stage C at the first diagnosis, and the vast majority of patients in the middle and advanced stages were no longer suitable for the first choice of surgical resection and should receive comprehensive treatment mainly consisting of local treatment and systemic treatment.
TACE is one of the most used treatments for liver cancer. At present, cTACE and DEB-TACE are mainly used. Drug-eluting beads, as new drug-carrying embolisms, have the advantages of loading chemotherapeutic drugs depending on charge and releasing drugs slowly within a certain time to improve local drug concentration. Based on the application of clinical practice, its efficacy has been well confirmed. DEB-TACE results in better tumor response and a similar safety profile than cTACE. However, for HCC at stage C of BCLC, due to the large tumor load and common portal invasion, it is difficult for a single TACE to achieve complete or partial remission, and a complete embolization is likely to increase the risk of serious complications.
Hepatic Arterial Infusion Chemotherapy is used to treat hepatic arterial infusion chemotherapy (HCC). HAIC requires chemotherapy drugs to be injected directly into the liver tumor via a percutaneous arterial cannula. HAIC drugs alone stay in the tumor for a short time, will be washed out quickly, and cannot be completely covered for tumors with external hepatic collateral circulation. However, unlike HAIC, DEB-TACE can embolize tumors to nourish arteries, rapidly lead to massive ischemic necrosis of tumors, and significantly prolong the contact time between cancer cells and chemotherapy drugs. In conclusion, the combination of DEB-TACE and HAIC can make up for the respective deficiencies of DEB-TACE and HAIC. And produce enhanced local anti-tumor effect and less AEs, especially in HCC with high tumor load.
The combination of DEB-TACE and HAIC has been well tolerated in the treatment of large liver cancer. However, most patients with BCLC stage C HCC have vascular invasion or extrahepatic metastasis, which cannot be treated surgically. Moreover, the progressive involvement of vascular invasion will eventually reduce blood flow and further deteriorate liver function, resulting in impaired liver function and poor prognosis. Therefore, we predict that the DEB-TACE sequential HAIC approach will reduce AEs while achieving good efficacy.
Therefore, based on previous studies, this study intended to select patients with unresectable primary liver cancer at stage C of BCLC in a multi-center setting, and prospectively observe the efficacy of DEB-TACE followed by FOLFOX-based HAIC in the treatment of unresectable BCLC stage C patients.
- Conditions
- HCC
- Being tested
- DEB-TACE and HAIC, DEB-TACE
- Keywords
- DEB-TACE- HAIC, DEB-TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACE and HAICProcedure or surgery
Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion
DEB-TACEProcedure or surgery
Drug-eluting bead transarterial chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE-HAIC | Experimental | Drug-eluting bead transarterial chemoembolization Sequential with FOLFOX-based chemotherapy hepatic artery infusion Receives: Procedure: DEB-TACE and HAIC |
| DEB-TACE | Active comparator | Drug-eluting bead transarterial chemoembolization Receives: Procedure: DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from the first DEB-TACE treatment to either radiological progression or death
Measured: Time from the first DEB-TACE treatment to either radiological progression or death or up to 36 months
Secondary outcomes (4)
Overall survival (OS)
Time from the first DEB-TACE treatment to death from any cause or the end of the study
Measured: Time from the first DEB-TACE treatment to death or up to 36 months
Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount
Measured: 1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first
Disease control rate (DCR)
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Measured: 1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first
Time to Progression (TTP)
Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST
Measured: Time from the first DEB-BACE treatment to either radiological progression up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start7 Mar 2023
- Primary completion7 Jun 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuhua Duan, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xuhua Xuhua, Ph.D., Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788835
- Sponsor's protocol ID
- 2023-KY-0081-002
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 29 Mar 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-eluting Bead Transarterial Chemoembolization and Drug-eluting Bead Transarterial Chemoembolization Sequential Hepatic Artery Chemotherapy Infusion for Unresectable BCLC Stage C HCC: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05788835
- Acronym / sponsor ID
- 2023-KY-0081-002
- Conditions
- HCC
- Keywords
- DEB-TACE- HAIC, DEB-TACE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xuhua DuanUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 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 is a randomized controlled trial to determine the efficacy and safety of DEB-TACE versus DEB-TACE sequential HAIC for unresectable BCLC stage C HCC
Detailed description
Primary liver cancer is one of the most common malignant tumors in the world. According to the survey results of the BRIDGE study, about 64% of Chinese patients with liver cancer had BCLC stage B and stage C at the first diagnosis, and the vast majority of patients in the middle and advanced stages were no longer suitable for the first choice of surgical resection and should receive comprehensive treatment mainly consisting of local treatment and systemic treatment.
TACE is one of the most used treatments for liver cancer. At present, cTACE and DEB-TACE are mainly used. Drug-eluting beads, as new drug-carrying embolisms, have the advantages of loading chemotherapeutic drugs depending on charge and releasing drugs slowly within a certain time to improve local drug concentration. Based on the application of clinical practice, its efficacy has been well confirmed. DEB-TACE results in better tumor response and a similar safety profile than cTACE. However, for HCC at stage C of BCLC, due to the large tumor load and common portal invasion, it is difficult for a single TACE to achieve complete or partial remission, and a complete embolization is likely to increase the risk of serious complications.
Hepatic Arterial Infusion Chemotherapy is used to treat hepatic arterial infusion chemotherapy (HCC). HAIC requires chemotherapy drugs to be injected directly into the liver tumor via a percutaneous arterial cannula. HAIC drugs alone stay in the tumor for a short time, will be washed out quickly, and cannot be completely covered for tumors with external hepatic collateral circulation. However, unlike HAIC, DEB-TACE can embolize tumors to nourish arteries, rapidly lead to massive ischemic necrosis of tumors, and significantly prolong the contact time between cancer cells and chemotherapy drugs. In conclusion, the combination of DEB-TACE and HAIC can make up for the respective deficiencies of DEB-TACE and HAIC. And produce enhanced local anti-tumor effect and less AEs, especially in HCC with high tumor load.
The combination of DEB-TACE and HAIC has been well tolerated in the treatment of large liver cancer. However, most patients with BCLC stage C HCC have vascular invasion or extrahepatic metastasis, which cannot be treated surgically. Moreover, the progressive involvement of vascular invasion will eventually reduce blood flow and further deteriorate liver function, resulting in impaired liver function and poor prognosis. Therefore, we predict that the DEB-TACE sequential HAIC approach will reduce AEs while achieving good efficacy.
Therefore, based on previous studies, this study intended to select patients with unresectable primary liver cancer at stage C of BCLC in a multi-center setting, and prospectively observe the efficacy of DEB-TACE followed by FOLFOX-based HAIC in the treatment of unresectable BCLC stage C patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE-HAIC | Experimental | Procedure: DEB-TACE and HAICDrug-eluting bead transarterial chemoembolization Sequential with FOLFOX-based chemotherapy hepatic artery infusion |
| DEB-TACE | Active comparator | Procedure: DEB-TACEDrug-eluting bead transarterial chemoembolization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).
- The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.
- Patient age between 18 and 75，male or female.
- ECOG 0-1.
- Expected life span ≥ 3 months.
Key exclusion criteria (10 listed)
- Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.
- Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
- Diffuse liver cancer patients.
- Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
- A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
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 |
|---|---|---|
| DEB-TACE and HAICDrug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion | Procedure or surgery | DEB-TACE-HAIC |
| DEB-TACEDrug-eluting bead transarterial chemoembolization | Procedure or surgery | DEB-TACE |
Primary outcome
Progression-free survival (PFS)
Time frame: Time from the first DEB-TACE treatment to either radiological progression or death or up to 36 months
Time from the first DEB-TACE treatment to either radiological progression or death
4 secondary outcomes
Overall survival (OS)
Time frame: Time from the first DEB-TACE treatment to death or up to 36 months
Objective response rate (ORR)
Time frame: 1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first
Disease control rate (DCR)
Time frame: 1, 3, 6,12 months after the first DEB-TACE treatment, up to death or 36 months, whichever came first
Time to Progression (TTP)
Time frame: Time from the first DEB-BACE treatment to either radiological progression up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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.
Xuhua Xuhua, Ph.D. principal investigator
The First Affiliated Hospital of Zhengzhou University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB-TACE and HAIC and DEB-TACE in people with HCC, run by Xuhua Duan at 16 sites 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 10 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Duan, Ph.D. (+8613523402912, xuhuaduan@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: Time from the first DEB-TACE treatment to either radiological progression or death or up to 36 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 29 Mar 2023.