Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Esophagogastric Varices
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transarterial chemoembolization combined with endoscopic therapy
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Qilu Hospital , Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
combined group
control group
Arm Description
unresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy
unresectable hepatocellular carcinoma patients who only received TACE
Outcomes
Primary Outcome Measures
Time of overall survival
Differences of overall survival between two groups
Number of bleeding episodes
Differences of bleeding episodes between two groups
Secondary Outcome Measures
Full Information
NCT ID
NCT05017922
First Posted
August 17, 2021
Last Updated
October 21, 2021
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05017922
Brief Title
Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
Official Title
Efficacy of TACE Combined With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Esophagogastric Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined group
Arm Type
Experimental
Arm Description
unresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy
Arm Title
control group
Arm Type
Other
Arm Description
unresectable hepatocellular carcinoma patients who only received TACE
Intervention Type
Procedure
Intervention Name(s)
transarterial chemoembolization combined with endoscopic therapy
Intervention Description
TACE: The tip of the catheter was advanced into tumor-feeding artery based on the tumor location and size. 5-Fu was injected. Then the chemolipiodolization was performed, using oxaliplatin, epirubicin and lipiodol. If stagnant flow did not realized, then injected pure lipiodol. If the tumor-feeding artery still cannot be completely embolized, several absorbable gelatin sponge particles would be injected. Endoscopic therapy: After the site of esophageal varices was identified by the gastroscopy, spiral ligation using the EVL device (COOK, MBL-6-F) was performed and ensure the varices were fully inhaled, 1-3 rubber bands were used totally. After EVL, water was sprayed to the ligation sites to check for bleeding. If gastric varices were found, EIS was performed using the 'sandwich method' of hypertonic glucose-tissue adhesive-normal saline. Make sure the needle entered the varieose vein before inject drugs, and repeated the injection if necessary.
Primary Outcome Measure Information:
Title
Time of overall survival
Description
Differences of overall survival between two groups
Time Frame
In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Title
Number of bleeding episodes
Description
Differences of bleeding episodes between two groups
Time Frame
In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Qilu Hospital , Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34926300
Citation
Tao Z, Ruan Y, Peng Z, Zhang K, Gao Y. Transarterial Chemoembolization Combined With Endoscopic Therapy Is Beneficial for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices. Front Oncol. 2021 Dec 2;11:783574. doi: 10.3389/fonc.2021.783574. eCollection 2021.
Results Reference
derived
Learn more about this trial
Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
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