Clinical trial · Interventional
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled 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)
Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Laser Ablation | — | UNRESOLVED | — |
| Portal Vein Tumor Thrombus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-CRT | Procedure | — | UNRESOLVED |
| LA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LA group
- description
- Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated.
- interventionNames
- Procedure: LA
- type
- EXPERIMENTAL
- label
- 3D-CRT group
- description
- γ-knife treatment with radiation dose of 48-63 Gy/6-9 times.
- interventionNames
- Procedure: 3D-CRT
Primary outcomes (3)
- measure
- Toxic and side effects caused by 3D-CRT or LA
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Child-Pugh class B liver function; 2. Preoperative ECOG criteria score of 0-2; 3. Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI); 4. Tumor thrombus in the second-order or more peripheral branch of portal vein; 5. Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm; 6. The expected survival time \>6 months. Exclusion Criteria: 1. Other anticancer treatment before treatment 2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer 3. Patients with other diseases that may affect the treatment of this treatment 4. History of other malignant tumors 5. Patients who are participating in other clinical trials 6. Pregnant, lactating women
References
Publications (0)
Data not yet available