Hepatocellular CarcinomaPhase 3ARTC-HCCNCT02125396
Adjuvant Radiotherapy Comparing TACE for Curative HCC
A Phase 3 study testing Transarterial chemoembolization and Radiotherapy in people with Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transarterial chemoembolization and Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
Nanning, Guangxi, 530021
Jian-Hong Zhong, MD, 86-771-5330855, zhongjianhong66@163.com
Jian-Hong Zhong, MD
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transarterial chemoembolization, Radiotherapy
- Keywords
- hepatocellular carcinoma, liver cancer, transarterial chemoembolization, radiotherapy, adjuvant therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolizationOther
Adjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)]
RadiotherapyOther
Adjuvant radiotherapy is used for postoperative curative HCC
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Adjuvant radiotherapy is used for postoperative curative HCC Receives: Other: Transarterial chemoembolization; Other: Radiotherapy |
| Transarterial chemoembolization | Active comparator | Adjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)] Receives: Other: Transarterial chemoembolization; Other: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survivals
Measured: 5 years
Secondary outcomes (1)
Recurrence rates
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study start1 May 2019
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125396
- Sponsor's protocol ID
- ARTC-HCC
- Acronym
- ARTC-HCC
- Status last verified
- Jan 2023
- First submitted
- 25 Apr 2014
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Radiotherapy Comparing Transarterial Chemoembolization for Curative Hepatocellular Carcinoma: a Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT02125396
- Acronym / sponsor ID
- ARTC-HCC / ARTC-HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, liver cancer, transarterial chemoembolization, radiotherapy, adjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Other: Transarterial chemoembolization, Other: RadiotherapyAdjuvant radiotherapy is used for postoperative curative HCC |
| Transarterial chemoembolization | Active comparator | Other: Transarterial chemoembolization, Other: RadiotherapyAdjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)] |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- History of cardiac disease:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial chemoembolizationAdjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)] | Other | Radiotherapy, Transarterial chemoembolization |
| RadiotherapyAdjuvant radiotherapy is used for postoperative curative HCC | Other | Radiotherapy, Transarterial chemoembolization |
Primary outcome
Overall survivals
Time frame: 5 years
1 secondary outcome
Recurrence rates
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transarterial chemoembolization and Radiotherapy in people with Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Hong Zhong, MD (86-771-5330855, zhongjianhong66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survivals (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023; AzTrials last refreshed its copy on 29 Oct 2026.