Clinical trial · Observational
Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE
Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Hepatocellular Carcinoma ≤5 cm With or Without Transcatheter Arterial Chemoembolization (TACE)
NCT04161287CI-TRIAL-00073575unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Hepatocellular Carcinoma | Small Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stereotactic Body Radiation Therapy | — | UNRESOLVED | — |
| Transcatheter Arterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transcatheter arterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SBRT with TACE
- interventionNames
- Procedure: transcatheter arterial chemoembolization
- label
- SBRT alone
Primary outcomes (3)
- measure
- Overall survival rates
- timeFrame
- From date of randomization until the date of death from any cause, assessed up to 36 months
- description
- OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
- measure
- Progression-free survival rates
- timeFrame
- From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
- description
- PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology * single lesion and longest tumor diameter ≤ 5.0 cm * CP-A or B classification * Eastern Cooperative Oncology Group (ECOG) score 0-1; * distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm * unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc. * rejecting other therapies such as resection, liver transplantation, etc. * platelet count≥50 × 109/L, white blood count≥1.5 × 109/L * patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative. Exclusion Criteria: * tumor thrombus * lymph node involvement * extrahepatic metastasis
References
Publications (5)
- RESULTSun J, Zhang T, Wang J, Li W, Zhang A, He W, Zhang D, Li D, Ding J, Duan X. Biologically effective dose (BED) of stereotactic body radiation therapy (SBRT) was an important factor of therapeutic efficacy in patients with hepatocellular carcinoma (</=5 cm). BMC Cancer. 2019 Aug 28;19(1):846. doi: 10.1186/s12885-019-6063-9. PMID 31455251
- RESULTZhang T, Sun J, He W, Li H, Piao J, Xu H, Duan X. Stereotactic body radiation therapy as an effective and safe treatment for small hepatocellular carcinoma. BMC Cancer. 2018 Apr 20;18(1):451. doi: 10.1186/s12885-018-4359-9. PMID 29678159
- RESULTSu TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9. PMID 27809890
- RESULTWong TC, Chiang CL, Lee AS, Lee VH, Yeung CS, Ho CH, Cheung TT, Ng KK, Chok SH, Chan AC, Dai WC, Wong FC, Luk MY, Leung TW, Lo CM. Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. Surg Oncol. 2019 Mar;28:228-235. doi: 10.1016/j.suronc.2019.01.006. Epub 2019 Jan 29. PMID 30851906
- RESULTTakayasu K, Arii S, Kudo M, Ichida T, Matsui O, Izumi N, Matsuyama Y, Sakamoto M, Nakashima O, Ku Y, Kokudo N, Makuuchi M. Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines. J Hepatol. 2012 Apr;56(4):886-92. doi: 10.1016/j.jhep.2011.10.021. Epub 2011 Dec 13. PMID 22173160