Clinical trial · Observational
Effect of DAAs on Behavior of HCC in HCV Patients
Effect of Direct Acting Antiviral Agents on Behavior of Hepatocellular Carcinoma and Overall Survival in Patients With Chronic Hepatitis C
NCT03200171CI-TRIAL-00052818completedClinicalTrials.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)
Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatitis C | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group I
- description
- HCC patients who received DAAs for chronic HCV previously (either responders or not)
- label
- Group II
- description
- HCC patients who are naive to DAAs.
Primary outcomes (2)
- measure
- Overall survival (OS)
- timeFrame
- 6 months - 3 years
- description
- he length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
- measure
- Behavior of hepatocellular carcinoma
- timeFrame
- 6 months - 3 years
- description
- Early recurrence, or rapid progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups: * Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not) * Group II: HCC patients who are naive to DAAs. Exclusion Criteria: * Patients who refuse to be enrolled in the study. * Patients with hepatitis B virus or any other causes of cirrhosis. * Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven. * HCC developed on transplanted liver.
References
Publications (1)
- RESULTReig M, Marino Z, Perello C, Inarrairaegui M, Ribeiro A, Lens S, Diaz A, Vilana R, Darnell A, Varela M, Sangro B, Calleja JL, Forns X, Bruix J. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol. 2016 Oct;65(4):719-726. doi: 10.1016/j.jhep.2016.04.008. Epub 2016 Apr 13. PMID 27084592