Clinical trial · Interventional
Recurrence Rate of Hepatocellular Carcinoma After Treatment of Chronic Hepatits C Patients With Direct Acting Antivirals: Randomized Controlled Phase 3 Trial
RECURRENCE RATE OF HEPATOCELLULAR CARCINOMA AFTER TREATMENT OF CHRONIC HEPATITIS C PATIENTS WITH DIRECT ACTING ANTIVIRALS: RANDOMIZED CONTROLLED PHASE 3 TRIAL (CAUTIOUS TRIAL)
NCT03551444CI-TRIAL-00033281CAUTIOUSunknownPhase 3ClinicalTrials.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)
* Unexpected results were published in 2016 showed increased aggressiveness and rates of HCC recurrence after curative treatment of HCC in HCV patients treated by DAAs achieving SVR. On the other hand, the retrospective analysis of ANRS study, did not observe an increased risk of HCC recurrence after DAAs treatment in patients who underwent curative HCC treatment. * Assess the recurrence rate of HCC in HCV infected patients with prior history of treated HCC who achieved rCR with and without administration of DAAs and assess the effect of its timing.
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 |
|---|---|---|---|
| Hepatitis C, Chronic | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of DAA-based treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Administration of DAA-based treatment (Arm 1)
- description
- Arm 1 will be divided into 2 groups by randomization according to a 1:1 ratio into: Group A: Administration of DAA-based treatment after 3 months of complete remission of HCC. Group B: Administration of DAA-based treatment after 6 months of complete remission of HCC.
- interventionNames
- Drug: Administration of DAA-based treatment
- type
- EXPERIMENTAL
- label
- Control arm (Arm 2)
- description
- Not receiving DAAs after complete remission of HCC and to be kept on follow-up
- interventionNames
- Drug: Administration of DAA-based treatment
Primary outcomes (1)
- measure
- Recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: more than or equal to 18 years old. * Confirmed HCV viremia by PCR. * CHILD Pugh "A". * HCC diagnosed by criteria according to AASLD guidelines. * HCC patients should have been treated prior to randomization by resection, or ablation and achieving rCR. Exclusion Criteria: * Patients below 18 old. * Patients with advanced liver condition. * Patients known HBV or HIV infection. * Prior history of liver transplantation. * HCC treatment but without rCR before randomization * Pregnancy and lactation. * Patients with other malignancies other than HCC.
References
Publications (7)
- BACKGROUNDConti F, Buonfiglioli F, Scuteri A, Crespi C, Bolondi L, Caraceni P, Foschi FG, Lenzi M, Mazzella G, Verucchi G, Andreone P, Brillanti S. Early occurrence and recurrence of hepatocellular carcinoma in HCV-related cirrhosis treated with direct-acting antivirals. J Hepatol. 2016 Oct;65(4):727-733. doi: 10.1016/j.jhep.2016.06.015. Epub 2016 Jun 24. PMID 27349488
- BACKGROUNDElgharably A, Gomaa AI, Crossey MM, Norsworthy PJ, Waked I, Taylor-Robinson SD. Hepatitis C in Egypt - past, present, and future. Int J Gen Med. 2016 Dec 20;10:1-6. doi: 10.2147/IJGM.S119301. eCollection 2017. PMID 28053553
- BACKGROUNDEuropean Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available. PMID 22424438
- BACKGROUNDEuropean Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2017 Jan;66(1):153-194. doi: 10.1016/j.jhep.2016.09.001. Epub 2016 Sep 22. No abstract available. PMID 27667367
- BACKGROUNDANRS collaborative study group on hepatocellular carcinoma (ANRS CO22 HEPATHER, CO12 CirVir and CO23 CUPILT cohorts). Electronic address: stanislas.pol@aphp.fr. Lack of evidence of an effect of direct-acting antivirals on the recurrence of hepatocellular carcinoma: Data from three ANRS cohorts. J Hepatol. 2016 Oct;65(4):734-740. doi: 10.1016/j.jhep.2016.05.045. Epub 2016 Jun 7. PMID 27288051
- BACKGROUNDNault JC, Colombo M. Hepatocellular carcinoma and direct acting antiviral treatments: Controversy after the revolution. J Hepatol. 2016 Oct;65(4):663-665. doi: 10.1016/j.jhep.2016.07.004. Epub 2016 Jul 12. No abstract available. PMID 27417216
- Torres HA, Vauthey JN, Economides MP, Mahale P, Kaseb A. Hepatocellular carcinoma recurrence after treatment with direct-acting antivirals: First, do no harm by withdrawing treatment. J Hepatol. 2016 Oct;65(4):862-864. doi: 10.1016/j.jhep.2016.05.034. Epub 2016 May 30. No abstract available.