Clinical trial · Interventional
HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial
Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: 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)
Data regarding hepatocellular carcinoma (HCC) recurrence after directly acting antivirals (DAAs) given for hepatitis C virus treatment are contradictory. Surprisingly, some studies reported that DAAs are accompanied with higher HCC recurrence. But, other studies showed no rise or even decrease in HCC recurrence. Most of these studies were retrospective and some were non-randomized prospective studies. Here investigators aim to perform a randomized controlled trial to study this issue.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis C | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Recurrence | — | UNRESOLVED | — |
| Treatment Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Velpatasvir/Sofosbuvir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- DAAs group
- description
- Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.
- interventionNames
- Drug: Velpatasvir/Sofosbuvir
- type
- ACTIVE_COMPARATOR
- label
- Postponed DAAs group
- description
- Those who will not start DAAs within the 12 months follow up from HCC ablation procedure. Patients of this group will receive DAAs provided that there is no HCC recurrence after the end of 1 year.
- interventionNames
- Drug: Velpatasvir/Sofosbuvir
Primary outcomes (1)
- measure
- HCC recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Child-Pugh A and B subjects with hepatitis C related \< 5 cm single or up to 3 hepatocellular carcinomas without any vascular or extrahepatic involvement Exclusion Criteria: * Those with positive HBsAg, history of alcohol consumption, patients with other known causes of chronic liver disease, patients who have received previous DAAs for HCV and patients who have received previous locoregional treatment for HCC will be excluded.
References
Publications (1)
- DERIVEDKamal A, Metawea M, Omar H, Ghallab M, Kassem A, Naguib H. Hepatitis C Virus-Related One-Year Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial. J Gastrointest Cancer. 2024 Jun;55(2):913-923. doi: 10.1007/s12029-024-01035-5. Epub 2024 Mar 4. PMID 38436921