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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangxi Medical University
• Treatments: Chlorotrianisene; Immune Checkpoint Inhibitors; Lenvatinib; Sorafenib

Criteria

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.