Clinical trial · Interventional
Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma
Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma: Phase II Trial
- 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)
Oligometastasis is a definition that has been described in the past in the 1990s, and in some patients, metastases are not extensive and are limited to a small number of metastases. The local ablative treatment for oligometastasis is not a new concept. In case of liver metastasis from colorectal cancer, long-term survival can be expected if the liver resection is performed. Effectiveness has been demonstrated in studies of adrenal and brain metastasis from lung cancer as well as lung metastasis from sarcoma. A recent non-randomized study reported that patients with oligometastasis improved treatment outcomes with aggressive treatment. This study demonstrated that local ablative treatment for oligometastasis showed better treatment outcomes than expected. Also, the long-term outcomes in SABR-COMET trial showed that the overall survival were increased by 22 months. So far, the standard treatment for metastatic disease is systemic chemotherapy. However, based on these results from studies, active local treatment for patients with oligometastasis is currently being performed in the clinic. In this study, we aimed to apply this concept to patients with hepatocellular carcinoma. To confirm the efficacy and safety of stereotactic radiotherapy in patients with oligometastasis hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastasis Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: Stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT arm
- description
- Patients will be treated with stereotactic body radiotherapy (SBRT) for oligometastasis from hepatocellular carcinoma
- interventionNames
- Radiation: Radiation: Stereotactic body radiotherapy (SBRT)
Primary outcomes (2)
- measure
- Treatment efficacy (Overall survival)
- timeFrame
- 2 year
- description
- The overall survival of patients from the start date of SBRT to either date of death or date of last follow up is evaluated
- measure
- Treatment efficacy (Disease free survival)
- timeFrame
- 2 year
- description
- The disease free survival from the start date of SBRT to date of disease progression or date of death or date of last follow up is evaluated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: i. 19 years or older ii. Patients who signed the informed consent form iii. The clinical trial protocol can be complied with at the discretion of the investigator iv. Performance status (based on ECOG) less than 2 (0, 1) v. Patients with life expectancy greater than 3 months vi. Condition in which primary cancer is controlled • Definition: A condition that has not progressed at the time of review of clinical trials after curative treatment of primary cancer 3 months ago vii. Number of metastatic lesions up to 5 viii. 3 or less metastatic lesions in one metastatic organ ix. Those who are undergoing targeted therapy or chemotherapy can also be included (during radiation therapy, drug treatment is stopped) Exclusion Criteria: i. Serious medical complications that cannot proceed with radiation therapy ii. Previous radiation therapy history at the location where radiation therapy is to be performed iii. malignant pleural effusion iv. When the spinal cord and the tumor are close (the tumor is located within 3 mm) v. In case of brain metastasis requiring surgical intervention
References
Publications (1)
- DERIVEDChoi SH, Lee BM, Kim J, Kim DY, Seong J. Efficacy of stereotactic ablative radiotherapy in patients with oligometastatic hepatocellular carcinoma: A phase II study. J Hepatol. 2024 Jul;81(1):84-92. doi: 10.1016/j.jhep.2024.03.003. Epub 2024 Mar 11. PMID 38467379