Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Esophagogastric Varices
• Interventions: Procedure: transarterial chemoembolization combined with endoscopic therapy

• Registration Number: NCT05017922
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with esophagogastric varices (EGV) and seek out predictors associated with survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2021-01-01
• Status Verified: 2021-07
• Study Completion: 2021-08-10
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• 1. HCC was diagnosed in accordance with the 2017 edition of diagnosis guidelines, all patients were in CNLC stage Ib to IIIa, and treated with TACE; 2. EGV was demonstrated through endoscopic examination; 3. Child-Pugh grade A or B, or grade C patients improved liver function to grade A or B through aggressive treatment; 4. age between 18 and 75 years.

Exclusion Criteria

• 1. HCC with diffuse or distant metastasis, or with other systemic malignancies; 2. severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 3. severe cardiac, cerebrovascular, lung and renal diseases and cannot tolerate endoscopic treatment; 4. severe coagulation dysfunction; 5. severe infection, bleeding with unstable vital signs; 6. history of liver surgery; 7. cannot or refuse to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined group	transarterial chemoembolization combined with endoscopic therapy	unresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy
control group	transarterial chemoembolization combined with endoscopic therapy	unresectable hepatocellular carcinoma patients who only received TACE

Primary Outcome Measures

Name	Time	Method
Number of bleeding episodes	In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years	Differences of bleeding episodes between two groups
Time of overall survival	In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years	Differences of overall survival between two groups

Trial Locations

Locations (1)

Qilu Hospital , Shandong University; 🇨🇳 Jinan, Shandong, China