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NCT03898921

RFA vs. SBRT for Small HCC

Status unknown Phase 3 Last updated 24 November 2020
What this trial tests

Phase 3 trial testing stereotactic body radiotherapy (SBRT) in Hepatocellular Carcinoma in 270 participants. Status unknown.

Timeline
10 March 2019
Primary endpoint
9 March 2021
8 March 2022

Quick facts

Lead sponsorSun Yat-sen University
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment270
Start date10 March 2019
Primary completion9 March 2021
Estimated completion8 March 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is one of the malignant tumors that seriously threaten the health of people. Its morbidity and mortality rank the third and the second among various malignant tumors in China, respectively. Local ablation therapy represented by radiofrequency ablation (RFA) has been recommended as a first-line treatment for small HCC by most international guidelines. Especially for central small HCC, RFA is considered the first-line choice. With the advancement of radiotherapy equipment and the development of precise imaging technology, stereotactic body radiotherapy (SBRT) has become one of the important treatments for liver cancer.Retrospective controlled studies have shown that SBRT is similar to RFA in treating small HCC, and the local control rate may be better than RFA. But there is no high-level evidence to support which treatment is superior. This project aims to conduct a phase III, prospective, randomized, open, parallel controlled clinical study of RFA versus SBRT for small HCC (solitary tumor≤ 5.0 cm). The results will provide potent evidence for the rational and effective treatment of early HCC and the improvement of clinical guidelines for HCC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current State of Liver-Directed Therapies and Combinatory Approaches with Systemic Therapy in Hepatocellular Carcinoma (HCC).
    Viveiros P, Riaz A, Lewandowski RJ, Mahalingam D. · · 2019 · cited 58× · PMID 31370248 · DOI 10.3390/cancers11081085
  2. Stereotactic body radiation therapy for hepatocellular carcinoma: From infancy to ongoing maturity.
    Lewis S, Dawson L, Barry A, Stanescu T, et al · · 2022 · cited 55× · PMID 35860434 · DOI 10.1016/j.jhepr.2022.100498
  3. The Current Role of Stereotactic Body Radiation Therapy (SBRT) in Hepatocellular Carcinoma (HCC).
    Kimura T, Fujiwara T, Kameoka T, Adachi Y, et al · · 2022 · cited 36× · PMID 36139545 · DOI 10.3390/cancers14184383
  4. Stereotactic Radiotherapy for Hepatocellular Carcinoma, Radiosensitization Strategies and Radiation-Immunotherapy Combination.
    Pérez-Romasanta LA, González-Del Portillo E, Rodríguez-Gutiérrez A, Matías-Pérez Á. · · 2021 · cited 28× · PMID 33430362 · DOI 10.3390/cancers13020192
  5. Local and Regional Therapies for Hepatocellular Carcinoma and Future Combinations.
    Hatzidakis A, Müller L, Krokidis M, Kloeckner R. · · 2022 · cited 17× · PMID 35626073 · DOI 10.3390/cancers14102469
  6. The role of stereotactic body radiotherapy in hepatocellular carcinoma: guidelines and evidences.
    Hu Y, Zhao C, Ji R, Chen W, et al · · 2022 · cited 10× · PMID 39036452 · DOI 10.1016/j.jncc.2022.05.002
  7. Local Therapies for Hepatocellular Carcinoma and Role of MRI-Guided Adaptive Radiation Therapy.
    Liu Y, Chou B, Yalamanchili A, Lim SN, et al · · 2023 · cited 6× · PMID 37240623 · DOI 10.3390/jcm12103517
  8. Stereotactic body radiation therapy (SBRT) in patients with hepatocellular cancer-a narrative review and expert opinion.
    Gerum S, Grambozov B, Roeder F. · · 2024 · cited 3× · PMID 39279965 · DOI 10.21037/jgo-23-771

Verify or expand the search:

Other trials of stereotactic body radiotherapy (SBRT)

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Sun Yat-sen University trials

Trials by the same sponsor.

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