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

Last updated: February 7, 2021
Sponsor: Guangxi Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Abdominal Cancer

Liver Disease

Treatment

N/A

Clinical Study ID

NCT04229355
DEEP
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 thatTACE 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 tostudy entry.
  • History of organ allograft.
  • Known or suspected allergy to the investigational agent or any agent given inassociation with this trial.
  • Any condition that is unstable or which could jeopardize the safety of the patient andhis/her compliance in the study.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have anegative 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 controlmeasures during the course of the trial.

Study Design

Total Participants: 90
Study Start date:
February 02, 2021
Estimated Completion Date:
December 30, 2022

Study 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.

Connect with a study center

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.