Clinical trial · Interventional
the Effect of Grazoprevir/Elbasvir and TACE vs. TACE Alone in Prolonging Survival of Patients With Non-resectable HCV Associated HCC.
Pilot Study to Assess the Effect of Grazoprevir/Elbasvir (ZEPATIER™) and Transarterial Chemoembolization (TACE) vs. TACE Alone in Prolonging Survival of Patients With Non-resectable HCV Associated Hepatocellular Carcinoma
- 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 and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world. Most patients with HCC present with either non-resectable tumor and/or severe underlying liver dysfunction, and are not suitable candidates for curative treatments by resection or transplantation. Thus, for the majority of patients with HCV related HCC, the only option is prolongation of life without a chance for cure. These patients generally have a poor prognosis with a median survival of less than 1 year. Arterial obstruction of branches of the hepatic artery and simultaneous infusion of chemotherapy (Trans-arterial chemo-embolization or TACE) induces ischemic tumor necrosis with a high rate of objective tumor responses (30-60%). Overall, the median survival after TACE for intermediate HCC is about 20 months, an improvement over supportive care. Treatment with Grazoprevir/Elbasvir showed excellent results in phase 3 studies for patients with HCV genotype 1 (a and b) and genotype 4 infection and is approved for HCV treatment in the USA, Europe and Israel. Anti-HCV therapies may influence HCC biology by decreasing inflammation and may thus alter the tumor microenvironment.
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 |
|---|---|---|---|
| HCV, HCC | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Grazoprevir/Elbasvir | Drug | — | UNRESOLVED |
| Medical records | Other | — | UNRESOLVED |
| Transarterial Chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCV patients with un-resectable HCC
- description
- HCV genotype 1 (a and b) cirrhotic patients (child pugh A compensated cirrhosis) with advanced and un-resectable HCC who are eligible for TACE . The patients will receive Grazoprevir/Elbasvir and Transarterial Chemoembolization. Their outcomes will be compared to the medical records of patients who underwent Transarterial Chemoembolization only, in the past.
- interventionNames
- Drug: Grazoprevir/Elbasvir
- Other: Medical records
- Procedure: Transarterial Chemoembolization
Primary outcomes (5)
- measure
- Overall survival
- timeFrame
- assessed up to 24 months
- description
- 15% or more increase in survival with the combination treatment of Grazoprevir/Elbasvir and TACE vs. historical control of TACE alone; Time Frame: from start of treatment to death from any cause, or last known date of survival
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with chronic HCV genotype 1 (a and b) infection and un-resectable HCC who are eligible for TACE 2. Ages 18-75 years 3. Willing to take part in a clinical trial and have signed an informed consent 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less 5. Child-Pugh liver function class A 6. Patients with expected survival of less than 1 year 7. Adequate hematologic function (plt≥60, 000 /L; Hb≥8.5 g/dl; and INR≤1.7 8. Adequate hepatic function (albumin ≥3.5 g/dl; total bilirubin, ≤2 mg/dl; ALT and AST ≤5 times the upper limit of the normal range) 9. Adequate renal function (serum creatinine ≤1.5 times the upper limit of normal range). Exclusion Criteria: 1. Patients unwilling to sign the informed consent 2. Patients unwilling or not capable to complete the anti-viral treatment with Grazoprevir/Elbasvir 3. CPT score \>7 4. Patients ineligible for TACE 5. Patients with contraindications to elbasvir/grazoprevir 6. Patients suffering from other underlying liver disease (HBV, HIV, PSC, PBC, AIH etc.) 7. Patients with malignancies other than HCC 8. Patients with previous anti-HCC treatment (RFA, TACE, SIRT or sorafenib) 9. Active alcohol or substance use 10. Previous liver transplantations 11. Child Pugh B or C cirrhosis 12. Total serum bilirubin \>1.9 mg/dL 13. Extra-hepatic spread (metastases) 14. Pregnant/lactating women, minors and disabled/incapacitated persons
References
Publications (0)
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