- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05017922
Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
October 21, 2021 updated by: Qilu Hospital of Shandong University
Efficacy of TACE Combined With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Qilu Hospital , Shandong University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: combined group
unresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy
|
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.
|
Other: control group
unresectable hepatocellular carcinoma patients who only received TACE
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of overall survival
Time Frame: 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
|
In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
|
Number of bleeding episodes
Time Frame: 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
|
In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
August 10, 2021
Study Registration Dates
First Submitted
August 17, 2021
First Submitted That Met QC Criteria
August 17, 2021
First Posted (Actual)
August 24, 2021
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 21, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021719-Tao
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatocellular Carcinoma
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCActive, not recruitingAdvanced Adult Hepatocellular Carcinoma | Child-Pugh Class A | Stage III Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular...United States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | BCLC Stage C Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI); Genentech, Inc.RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC v7 and other conditionsUnited States, Canada, Puerto Rico
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingAdvanced Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | Metastatic Hepatocellular Carcinoma | BCLC Stage A Hepatocellular CarcinomaUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)CompletedStage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular CarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; American Society of Clinical Oncology; Radiological... and other collaboratorsWithdrawnHepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma AJCC v8 | Stage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Stage... and other conditionsUnited States
Clinical Trials on transarterial chemoembolization combined with endoscopic therapy
-
Zagazig UniversityCompletedHepatocellular Carcinoma
-
Sherief Abd-ElsalamTanta UniversityRecruiting
-
Brno University HospitalMasaryk University; Masaryk Memorial Cancer InstituteCompletedHepatocellular Carcinoma | Hepatocellular Carcinoma by BCLC Stage
-
Guangxi Medical UniversityCompletedHepatocellular CarcinomaChina
-
Translational Research in OncologyBayerRecruitingCarcinoma, HepatocellularSpain, Taiwan, Japan, United States, Korea, Republic of, Georgia, Germany, France, Turkey, Italy, Belgium, Hong Kong, Serbia
-
Dalin Tzu Chi General HospitalBuddhist Tzu Chi General Hospital; Hualien Tzu Chi General HospitalRecruitingHepatocellular Carcinoma(HCC)Taiwan
-
Zhejiang UniversityShandong Cancer Hospital and Institute; First Hospital of China Medical University and other collaboratorsRecruitingHepatocellular Carcinoma | Adjuvant TherapyChina
-
Zhejiang UniversityTerminated
-
Ain Shams UniversityCompletedHepatocellular Carcinoma (HCC)
-
Ohio State University Comprehensive Cancer CenterVarian Medical SystemsCompletedChild-Pugh Class A | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Child-Pugh Class BUnited States