Hepatocellular CarcinomaPhase 3NCT03988998
Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma
A Phase 3 study testing Radiofrequency ablation with radiotherapy and Radiofrequency ablation alone in people with Hepatocellular Carcinoma, run by Guangxi Medical University.
Trial summary
Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. 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?
- Radiofrequency ablation with radiotherapy and Radiofrequency ablation alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2022to 31 Jan 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
- Clinical diagnoses of hepatocellular carcinoma based on EASL.
- Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
- Patients must have a performance status of ECOG score < 2.
- Patients must have adequate liver reservation and adequate hemogram.
- Pugh-Child's Score < 7.
- The serum total bilirubin level are < 2 mg/dl.
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- The prothrombin times are < 3 sec above normal control.
- The platelet are > 75 x 109/L.
- Patient must have serum creatinine < 1.5 mg/dl
- Cardiac function with NYHA classification < Grade II
- HBsAg (+) .
- Signed informed consent.
Who cannot join
- HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
- Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
- Patients with advanced second primary malignancy are not eligible.
- Patients with pregnancy or breast-feeding are not eligible.
- Patients with severe cardiopulmonary diseases are not eligible.
- Patients with clinically significant psychiatric disorder are not eligible.
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- Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
- Patients who had prior antitumor therapy for HCC are not eligible.
- Anti-HCV positive patients are not eligible.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radiofrequency ablation with radiotherapy, Radiofrequency ablation alone
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation with radiotherapyDrug
Radiofrequency ablation with radiotherapy
Radiofrequency ablation aloneDrug
Radiofrequency ablation without radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation with radiotherapy | Experimental | Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma. Receives: Drug: Radiofrequency ablation with radiotherapy |
| Radiofrequency ablation alone | Active comparator | Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma. Receives: Drug: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 2-years recurrence rate
Two year recurrence rate between the two groups will be compared.
Measured: 2 year
Secondary outcomes (2)
the 2-years recurrence-free survival
Two year recurrence-free survival between the two groups will be compared.
Measured: 2 year
the 2-years overall survival.
Two year overall survival between the two groups will be compared.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start10 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- Radiofrequency Ablation with or without Radiotherapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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
- Investigators
- Tang Wei-Zhong, PhD, Study chair, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988998
- Sponsor's protocol ID
- FARTHER
- Status last verified
- Jan 2022
- First submitted
- 13 Jun 2019
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30.
PubMed 26628466Seo YS, Kim MS, Yoo HJ, Jang WI, Paik EK, Han CJ, Lee BH. Radiofrequency ablation versus stereotactic body radiotherapy for small hepatocellular carcinoma: a Markov model-based analysis. Cancer Med. 2016 Nov;5(11):3094-3101. doi: 10.1002/cam4.893. Epub 2016 Oct 5.
PubMed 27709795Hara K, Takeda A, Tsurugai Y, Saigusa Y, Sanuki N, Eriguchi T, Maeda S, Tanaka K, Numata K. Radiotherapy for Hepatocellular Carcinoma Results in Comparable Survival to Radiofrequency Ablation: A Propensity Score Analysis. Hepatology. 2019 Jun;69(6):2533-2545. doi: 10.1002/hep.30591. Epub 2019 May 2.
PubMed 30805950Kim N, Kim HJ, Won JY, Kim DY, Han KH, Jung I, Seong J. Retrospective analysis of stereotactic body radiation therapy efficacy over radiofrequency ablation for hepatocellular carcinoma. Radiother Oncol. 2019 Feb;131:81-87. doi: 10.1016/j.radonc.2018.12.013. Epub 2018 Dec 31.
PubMed 30773192
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03988998
- Acronym / sponsor ID
- FARTHER
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 18 Jun 2019 (actual)
- 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.
Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Radiofrequency Ablation with or without Radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation with radiotherapy | Experimental | Drug: Radiofrequency ablation with radiotherapyPatients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma. |
| Radiofrequency ablation alone | Active comparator | Drug: Radiofrequency ablation alonePatients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical diagnoses of hepatocellular carcinoma based on EASL.
- Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
- Patients must have a performance status of ECOG score < 2.
- Patients must have adequate liver reservation and adequate hemogram.
- Patient must have serum creatinine < 1.5 mg/dl
Key exclusion criteria (9 listed)
- HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
- Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
- Patients with advanced second primary malignancy are not eligible.
- Patients with pregnancy or breast-feeding are not eligible.
- Patients with severe cardiopulmonary diseases are not eligible.
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 |
|---|---|---|
| Radiofrequency ablation with radiotherapyRadiofrequency ablation with radiotherapy | Drug | Radiofrequency ablation with radiotherapy |
| Radiofrequency ablation aloneRadiofrequency ablation without radiotherapy | Drug | Radiofrequency ablation alone |
Primary outcome
the 2-years recurrence rate
Time frame: 2 year
Two year recurrence rate between the two groups will be compared.
2 secondary outcomes
the 2-years recurrence-free survival
Time frame: 2 year
the 2-years overall survival.
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Background: PubMed 26628466Wahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30.
- Background: PubMed 27709795Seo YS, Kim MS, Yoo HJ, Jang WI, Paik EK, Han CJ, Lee BH. Radiofrequency ablation versus stereotactic body radiotherapy for small hepatocellular carcinoma: a Markov model-based analysis. Cancer Med. 2016 Nov;5(11):3094-3101. doi: 10.1002/cam4.893. Epub 2016 Oct 5.
- Background: PubMed 30805950Hara K, Takeda A, Tsurugai Y, Saigusa Y, Sanuki N, Eriguchi T, Maeda S, Tanaka K, Numata K. Radiotherapy for Hepatocellular Carcinoma Results in Comparable Survival to Radiofrequency Ablation: A Propensity Score Analysis. Hepatology. 2019 Jun;69(6):2533-2545. doi: 10.1002/hep.30591. Epub 2019 May 2.
- Background: PubMed 30773192Kim N, Kim HJ, Won JY, Kim DY, Han KH, Jung I, Seong J. Retrospective analysis of stereotactic body radiation therapy efficacy over radiofrequency ablation for hepatocellular carcinoma. Radiother Oncol. 2019 Feb;131:81-87. doi: 10.1016/j.radonc.2018.12.013. Epub 2018 Dec 31.
- Individual participant dataSharing planned: No
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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.
Tang Wei-Zhong, PhD study chair
Guangxi Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiofrequency ablation with radiotherapy and Radiofrequency ablation alone in people with Hepatocellular Carcinoma, run by Guangxi Medical University.
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 12 inclusion and 9 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Zhong Jian-Hong, PhD (0771-5301253, zhongjianhong@gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 2-years recurrence rate (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988998, which also lists 4 linked publications.
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 18 Jan 2022.