DEB-TACE Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular Carcinoma
Drug-eluting Bead Transarterial Chemoembolization Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular Carcinoma: a Multicentric Prospective Study
1 other identifier
interventional
90
1 country
1
Brief Summary
Transarterial chemoembolization (TACE) based on drug-eluting beads (DEB-TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the long-term survival is still low after DEB-TACE treatment. In recent years, lenvatinib and anti-PD-1 have exhibited potential therapeutic effects for advanced HCC. And sorafenib is the standard drug for advanced HCC. Combining targeted drugs or immunotherapies with DEB-TACE may provide synergistic effects and facilitate the development of personalized medicine. Therefore, this prospective study aims to investigate the safety and efficacy of DEB-TACE plus sorafenib or lenvatinib or PD-1 Inhibitor for unresectable HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hepatocellular-carcinoma
Started Feb 2021
Shorter than P25 for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedFebruary 9, 2021
February 1, 2021
1.9 years
January 12, 2020
February 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Primary endpoint is progression-free survival (PFS).
one month
Secondary Outcomes (1)
Overall survival
one month
Study Arms (3)
DEB-TACE plus Sorafenib
EXPERIMENTALPatients with unresectable hepatocellular carcinoma (HCC) in this group will receive drug-eluting bead transarterial chemoembolization (DEB-TACE).And then, they will receive sorafenib (400 mg/d, po, bid) one week after DEB-TACE therapy. The second DEB-TACE will be performed after one month later the first DEB-TACE. Lenvatinib will be taken orally for six months, untill tumor progression, or intolerable adverse reactions.
DEB-TACE plus Lenvatinib
EXPERIMENTALPatients with unresectable hepatocellular carcinoma (HCC) in this group will receive drug-eluting bead transarterial chemoembolization (DEB-TACE).And then, they will receive lenvatinib (8 mg/d, po, qd) one week after DEB-TACE therapy. The second DEB-TACE will be performed after one month later the first DEB-TACE. Lenvatinib will be taken orally for six months, untill tumor progression, or intolerable adverse reactions.
DEB-TACE plus PD-1 inhibitor
ACTIVE COMPARATORPatients with unresectable hepatocellular carcinoma (HCC) in this group will receive drug-eluting bead transarterial chemoembolization (DEB-TACE).And then, they will receive PD-1 inhibitor (200 mg, iv, 3 weeks) one week after DEB-TACE therapy. The second DEB-TACE will be performed after one month later the first DEB-TACE. PD-1 inhibitor will be taken for six months, untill tumor progression, or intolerable adverse reactions.
Interventions
Drug-eluting bead transarterial chemoembolization plus sorafenib (400 mg/d, po, bid)
Drug-eluting bead transarterial chemoembolization plus lenvatinib (8 mg/d, po, qd)
Drug-eluting bead transarterial chemoembolization plus PD-1 inhibitor
Eligibility Criteria
You may qualify if:
- Age 18 - 75 years
- Patients with unresectable primary hepatocellular carcinoma.
- With Child-Pugh A liver function.
You may not qualify if:
- Patients received targeted drugs, anti-PD1, or anti-PD-L1 treatment.
- Patients with recurrent hepatocellular carcinoma.
- Patient compliance is poor.
- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed.
- Known history of human immunodeficiency virus (HIV) infection.
- Known Central Nervous System tumors including metastatic brain disease.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- History of organ allograft.
- Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Related Publications (5)
Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.
PMID: 29433850BACKGROUNDHatanaka T, Kakizaki S, Nagashima T, Namikawa M, Tojima H, Shimada Y, Takizawa D, Naganuma A, Arai H, Sato K, Harimoto N, Shirabe K, Uraoka T. Analyses of objective response rate, progression-free survival, and adverse events in hepatocellular carcinoma patients treated with lenvatinib: A multicenter retrospective study. Hepatol Res. 2020 Mar;50(3):382-395. doi: 10.1111/hepr.13460. Epub 2019 Dec 10.
PMID: 31760660BACKGROUNDKim JJ, McFarlane T, Tully S, Wong WWL. Lenvatinib Versus Sorafenib as First-Line Treatment of Unresectable Hepatocellular Carcinoma: A Cost-Utility Analysis. Oncologist. 2019 Nov 20:theoncologist.2019-0501. doi: 10.1634/theoncologist.2019-0501. Online ahead of print.
PMID: 31748341BACKGROUNDFeng Z, Rong P, Wang W. Meta-analysis of the efficacy and safety of PD-1/PD-L1 inhibitors administered alone or in combination with anti-VEGF agents in advanced hepatocellular carcinoma. Gut. 2020 Oct;69(10):1904-1906. doi: 10.1136/gutjnl-2019-320116. Epub 2019 Dec 18. No abstract available.
PMID: 31852768BACKGROUNDXie ZB, Wang XB, Peng YC, Zhu SL, Ma L, Xiang BD, Gong WF, Chen J, You XM, Jiang JH, Li LQ, Zhong JH. Systematic review comparing the safety and efficacy of conventional and drug-eluting bead transarterial chemoembolization for inoperable hepatocellular carcinoma. Hepatol Res. 2015 Jan;45(2):190-200. doi: 10.1111/hepr.12450. Epub 2014 Dec 24.
PMID: 25388603BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Le-Qun Li, PhD
Guangxi Medical University Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessor will be blinded about patients' allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 12, 2020
First Posted
January 18, 2020
Study Start
February 2, 2021
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
February 9, 2021
Record last verified: 2021-02