Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

NCT03988998 | Unknown Phase 3

• 1 other identifier: FARTHER
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• the 2-years recurrence rate

  Two year recurrence rate between the two groups will be compared.

  2 year

Secondary Outcomes (2)

• the 2-years recurrence-free survival

  2 year

• the 2-years overall survival.

  2 year

Study Arms (2)

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.

Drug: Radiofrequency ablation with radiotherapy

Radiofrequency ablation alone

ACTIVE COMPARATOR

Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.

Drug: Radiofrequency ablation alone

Interventions

Radiofrequency ablation with radiotherapy DRUG

Radiofrequency ablation with radiotherapy

Radiofrequency ablation with radiotherapy

Radiofrequency ablation alone DRUG

Radiofrequency ablation without radiotherapy

Radiofrequency ablation alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Related Publications (4)

• 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.

  PMID: 26628466 BACKGROUND

• Seo 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.

  PMID: 27709795 BACKGROUND

• Hara 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.

  PMID: 30805950 BACKGROUND

• Kim 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.

  PMID: 30773192 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tang Wei-Zhong, PhD

  Guangxi Medical University

  STUDY CHAIR

Central Study Contacts

Zhong Jian-Hong, PhD

CONTACT

0771-5301253; zhongjianhong@gxmu.edu.cn

Xiang Bang-De, PhD

CONTACT

0771-5301253; xiangbangde@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes (recurrence or death) Assessor is blind about the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Radiofrequency Ablation with or without Radiotherapy

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 18, 2019
• Study Start: January 10, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share