Clinical trial · Interventional
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma: a Study on the Proof of Treatment Concept and Exploration of Selection Criteria for Clinical Application
NCT04780802CI-TRIAL-00061624completedN/AClinicalTrials.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)
To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The balloon catheter is placed at the various arterial feeders of the tumor | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ballloon catheter
- description
- Balloon-assisted transarterial therapy will be performed in the first treatment session only
- interventionNames
- Procedure: The balloon catheter is placed at the various arterial feeders of the tumor
Primary outcomes (2)
- measure
- The change in hemodynamics of arterial blood supply to HCC tumors
- timeFrame
- immediately after completion of procedure
- description
- The change in number of feeding arteries
- measure
- The change in the perfusion pattern of HCC tumors
- timeFrame
- immediately after completion of procedure
- description
- The change in perfusion pressure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients of age above 18 years 2. Patients who are indicated for transarterial treatment for HCC 3. Child-Pugh A or B cirrhosis 4. Eastern Cooperative Oncology Group performance score 0 or 1 5. BCLC A or B 6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy), 7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology. 8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen. 9. No invasion of portal vein or hepatic vein 10. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions) 11. Total tumor mass \< 50% liver volume 12. Size of any individual tumor \<= 7cm in largest dimension 13. Serum creatinine \< 130 umol/L or Creatinine clearance \> 55 ml/min. Exclusion Criteria: 1. Concurrent ischemic heart disease or heart failure 2. History of asthma, chronic obstructive airway disease or respiratory decompensation. 3. History of acute tumor rupture presenting with hemo-peritoneum 4. Biliary obstruction not amenable to percutaneous or endoscopic drainage 5. Child-Pugh C cirrhosis 6. History of hepatic encephalopathy 7. Intractable ascites not controllable by medical therapy 8. History of variceal bleeding within last 3 months 9. Serum total bilirubin level \> 50 umol/L 10. Serum albumin level \< 26 g/L 11. INR \> 1.3 12. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) 13. Arterio-portal venous shunt affecting \>1 hepatic segment on CT 14. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
References
Publications (0)
Data not yet available
No reference posted for this study.