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

  • STATUS
    Recruiting
  • days left to enroll
    33
  • participants needed
    90
  • sponsor
    Guangxi Medical University
Updated on 16 February 2021

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.

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.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment DEB-TACE plus Sorafenib, DEB-TACE plus Lenvatinib, DEB-TACE plus PD-1 inhibitor
Clinical Study IdentifierNCT04229355
SponsorGuangxi Medical University
Last Modified on16 February 2021

Eligibility

Yes No Not Sure

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
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