DEB-TACE Versus DEB-TACE Sequential HAIC for Unresectable BCLC Stage C HCC; A Randomized Controlled Trial
NCT ID: NCT05788835
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2023-03-07
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DEB-TACE-HAIC
Drug-eluting bead transarterial chemoembolization Sequential with FOLFOX-based chemotherapy hepatic artery infusion
DEB-TACE and HAIC
Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion
DEB-TACE
Drug-eluting bead transarterial chemoembolization
DEB-TACE
Drug-eluting bead transarterial chemoembolization
Interventions
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DEB-TACE and HAIC
Drug-eluting bead transarterial chemoembolization sequential Hepatic Artery Chemotherapy Infusion
DEB-TACE
Drug-eluting bead transarterial chemoembolization
Eligibility Criteria
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Inclusion Criteria
2. The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.
3. Patient age between 18 and 75，male or female.
4. ECOG 0-1.
5. Expected life span ≥ 3 months.
6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
7. Child-Pugh A-B.
8. HBV DNA\<2000 IU/ml.
9. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
10. Patients sign informed consent, good compliance, cooperate with treatment.
Exclusion Criteria
2. 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.
3. Diffuse liver cancer patients.
4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
5. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
6. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
7. 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.
8. Systemic failure, estimated survival time \<3 months.
9. Severe renal dysfunction.
10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.
18 Years
75 Years
ALL
No
Sponsors
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Xuhua Duan
OTHER
Responsible Party
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Xuhua Duan
Associate Professor
Principal Investigators
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Xuhua Xuhua, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Luo He Central Hospital
Luohe, Henan, China
Luo Yang Central Hospital
Luoyang, Henan, China
Deng zhou People's Hospital
Nanyang, Henan, China
Nan Yang Central Hospital
Nanyang, Henan, China
General Hospital of Pingmei Shenma Group
Pingdingshan, Henan, China
First People's Hospital of Shangqiu
Shangqiu, Henan, China
Shangqiu Municipal Hospital
Shangqiu, Henan, China
Xin Yang Central Hospital
Xinyang, Henan, China
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Zhou Kou Central Hospital
Zhoukou, Henan, China
First People's Hospital of Zhu Madian
Zhumadian, Henan, China
Zhu Ma Dian Central Hospital
Zhumadian, Henan, China
Zhu Madian Traditional Chinese Medicine Hospital
Zhumadian, Henan, China
Second People's Hospital of Jiaozuo
Jiaozuo, , China
Countries
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Central Contacts
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Facility Contacts
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Yaoxian Liu
Role: primary
Fazhong Li
Role: primary
Yanliang Li
Role: primary
Yangao Ma
Role: primary
Peixin Zhu
Role: primary
Limin Xie
Role: primary
Baoning Guo
Role: primary
Kun Du
Role: primary
Jun Lv
Role: primary
Haibo Wang
Role: primary
Cheng Xing
Role: primary
Lin Wei
Role: primary
Hui Yu
Role: primary
Shutang Yuan
Role: primary
Chuntang Qin
Role: primary
Other Identifiers
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2023-KY-0081-002
Identifier Type: -
Identifier Source: org_study_id
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