DEB-TACE Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular Carcinoma

February 7, 2021 updated by: Jian-Hong Zhong, Guangxi Medical University

Drug-eluting Bead Transarterial Chemoembolization Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular Carcinoma: a Multicentric Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. Most patients with HCC are diagnosed as advanced stage or unresectable disease because of the lack of signs and symptoms. Despite significant research efforts, only a few effective treatment approaches have been developed for HCC. Conventional transarterial chemoembolization (cTACE) is widely used as a palliative treatment for inoperable HCC. TACE based on drug-eluting beads (DEB-TACE) has recently been introduced into the clinic. This technique relies on drug-loaded microspheres to embolize and release antitumor medication gradually and locally in order to maximize local ischemia and tumor necrosis. Nowadays, many RCTs and meta-analyses found DEB-TACE is associated with higher overall survival than cTACE for unresectable HCC. However, the long-term survival is still low after DEB-TACE treatment. In recent years, targeted drugs (such as sorafenib, lenvatinib) and immune checkpoint inhibitor (anti-PD-1) have exhibited potential therapeutic effects for advanced HCC. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced HCC. Combining targeted drugs or immunotherapies with conventional therapeutic approaches may provide synergistic effects and facilitate the development of personalized medicine. However, it is still unknown which is the best combining treatment. 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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 - 75 years
  • Patients with unresectable primary hepatocellular carcinoma.
  • With Child-Pugh A liver function.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEB-TACE plus Sorafenib
Patients 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.
Drug: DEB-TACE plus Sorafenib
Drug-eluting bead transarterial chemoembolization plus sorafenib (400 mg/d, po, bid)
Experimental: DEB-TACE plus Lenvatinib
Patients 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.
Drug: DEB-TACE plus Lenvatinib
Drug-eluting bead transarterial chemoembolization plus lenvatinib (8 mg/d, po, qd)
Active Comparator: DEB-TACE plus PD-1 inhibitor
Patients 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.
Drug: DEB-TACE plus PD-1 inhibitor
Drug-eluting bead transarterial chemoembolization plus PD-1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: one month
Primary endpoint is progression-free survival (PFS).
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: one month
Overall survival is measured from the date of enrollment until the date of death from any cause. Patients who is lost to follow-up are censored at the last date they are known to be alive, and patients who remain alive are censored at the time of data cutoff.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Study Chair: Le-Qun Li, PhD, Guangxi Medical University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 2, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

January 12, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 7, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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