Adjuvant Radiotherapy Comparing TACE for Curative HCC
ARTC-HCC
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hepatocellular-carcinoma
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJanuary 27, 2023
January 1, 2023
4.3 years
April 25, 2014
January 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survivals
5 years
Secondary Outcomes (1)
Recurrence rates
5 years
Study Arms (2)
Radiotherapy
EXPERIMENTALAdjuvant radiotherapy is used for postoperative curative HCC
Transarterial chemoembolization
ACTIVE COMPARATORAdjuvant transarterial chemoembolization \[5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)\]
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
Nanning, Guangxi, 530021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Affiliated Tumor Hospital
Study Record Dates
First Submitted
April 25, 2014
First Posted
April 29, 2014
Study Start
May 1, 2019
Primary Completion
September 1, 2023
Study Completion
October 1, 2023
Last Updated
January 27, 2023
Record last verified: 2023-01