Clinical trial · Interventional
Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced 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)
CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.
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 Virus Chronic Infection | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP 675,206 | Biological | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Secondary outcomes (1)
- measure
- Changes in Hepatitis C Virus (HCV) viral load
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unequivocal diagnosis of HCC * unresectable disease not amenable to locoregional treatment. * a 4-week washout period after sorafenib or any other systemic agent * a 2-month washout period after internal or external radiation * HCV chronic infection * Child-Pugh stage A or B * Measurable disease according to RECIST criteria * ECOG \< 2 * expected survival \> 3 months * Adequate liver, renal and blood functions * ability to sign informed consent Exclusion Criteria: * previous treatment with an anti-CTL-4 agent * serious infections or disease compromising general health status * autoimmune disease that requires therapy * treatment with immunosuppressors * treatment with investigational agents * other neoplasms except skin and bladder superficial tumors * pregnancy or lactation * SNC metastasis * HIV infection * relevant heart disease (NYHA class III or IV)
References
Publications (1)
- DERIVEDSangro B, Gomez-Martin C, de la Mata M, Inarrairaegui M, Garralda E, Barrera P, Riezu-Boj JI, Larrea E, Alfaro C, Sarobe P, Lasarte JJ, Perez-Gracia JL, Melero I, Prieto J. A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. J Hepatol. 2013 Jul;59(1):81-8. doi: 10.1016/j.jhep.2013.02.022. Epub 2013 Mar 4. PMID 23466307