Clinical trial · Interventional
Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma
Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study
- 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 prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.
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 |
|---|---|---|---|
| Microwave Ablation | — | UNRESOLVED | — |
| Recurrent Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microwave ablation (MWA) | Device | — | UNRESOLVED |
| stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MWA
- description
- Patients receive microwave ablation (MWA)
- interventionNames
- Device: microwave ablation (MWA)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- Patients receive stereotactic body radiotherapy (SBRT)
- interventionNames
- Radiation: stereotactic body radiotherapy (SBRT)
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years old and above. 2. Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.) 3. Small hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis 4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency 5. The neutrophil count is at least 1.0\*10\^9/ml, and the platelet count is at least 50\*10\^9/ml. Hemoglobin is at least 80g/L. 6. Men or women with fertility are willing to take contraceptive measures during the trial 7. Eastern Cooperative Oncology Group score 0-1 points 8. Expected survival period \> 3 months 9. Voluntary participation and signing of informed consent Exclusion Criteria: 1. Patients who have undergone chemoradiation or targeted therapy for liver cancer 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points 3. Total bilirubin \>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times. 4. Patients undergoing major surgery within 1 month of study initiation 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years) 6. Researchers consider it inappropriate to participate in the test
References
Publications (0)
Data not yet available