- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125396
Adjuvant Radiotherapy Comparing TACE for Curative HCC (ARTC-HCC)
January 25, 2023 updated by: Jian-Hong Zhong, Guangxi Medical University
Adjuvant Radiotherapy Comparing Transarterial Chemoembolization for Curative Hepatocellular Carcinoma: a Randomized Controlled Trials
Despite advances in our understanding of hepatocellular carcinoma (HCC) and its diagnosis, the prognosis for patients with HCC remains disheartening, due to a high recurrence rate and frequent intrahepatic metastasis.
Various therapies for use after hepatic resection have been reported, but they are associated with adverse side effects or they fail to improve overall survival.
Nowadays, adjuvant transarterial chemoembolization (TACE) is recommended as the most effective therapy for postoperative HCC.
And the indication is patients with risk factors of recurrence.
While more and more prospective studies revealed that radiotherapy is effective for advanced HCC.
And the side effects of radiotherapy are controlled.
Until now, no prospective or retrospective study compared the efficacy of adjuvant TACE and radiotherapy for postoperative HCC.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jian-Hong Zhong, MD
- Phone Number: 86-771-5330855
- Email: zhongjianhong66@163.com
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Recruiting
- Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
-
Contact:
- Jian-Hong Zhong, MD
- Phone Number: 86-771-5330855
- Email: zhongjianhong66@163.com
-
Principal Investigator:
- Jian-Hong Zhong, MD
-
-
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:
- Age 18-75 years
- Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
- Patients have Child-Pugh A liver function and undergo potentially curative hepatic resection
- Patients with risk factors for recurrence (tumor size >5 cm, multiple nodules, vascular invasion, absence of tumor capsule, poorly differentiated tumor, and narrow resection margin)
- No previous treatment of HCC except liver resection
- No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- No malignancy other than HCC for 5 years prior to the initial HCC treatment
- No imaging evidence of invasion into the major portal/hepatic vein branches
- No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
Exclusion Criteria:
History of cardiac disease:
- congestive heart failure > New York Heart Association (NYHA) class 2;
- active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
- cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
- uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
- Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
- 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
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- 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.
Excluded therapies and medications, previous and concomitant:
- Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
- Prior use of systemic investigational agents for HCC
- Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiotherapy
Adjuvant radiotherapy is used for postoperative curative HCC
|
Adjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)]
Adjuvant radiotherapy is used for postoperative curative HCC
|
Active Comparator: Transarterial chemoembolization
Adjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)]
|
Adjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)]
Adjuvant radiotherapy is used for postoperative curative HCC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survivals
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence rates
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2019
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
April 25, 2014
First Submitted That Met QC Criteria
April 25, 2014
First Posted (Estimate)
April 29, 2014
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 25, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARTC-HCC
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.
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