Clinical trial · Interventional
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma
A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment
NCT00943449CI-TRIAL-00013489SheltercompletedPhase 2ClinicalTrials.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)
The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4SC-201 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 4SC-201
- interventionNames
- Drug: 4SC-201
- type
- EXPERIMENTAL
- label
- 4SC-201 + Sorafenib
- interventionNames
- Drug: 4SC-201
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201
- timeFrame
- 12 weeks
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Advanced stage hepatocellular carcinoma * Patients exhibiting progressive disease under Sorafenib treatment * Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included * ECOG performance status 0, 1 or 2 * Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks Main Exclusion Criteria: * Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) - any cancer curatively treated \> 3 years prior to entry is permitted * Renal failure requiring hemo- or peritoneal dialysis * Known central nervous system (CNS) tumors including symptomatic brain metastasis * Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy \> Grade I * Pregnant or breastfeeding women * Sorafenib intolerance * Major surgery within the last 4 weeks
References
Publications (1)
- DERIVEDBitzer M, Horger M, Giannini EG, Ganten TM, Worns MA, Siveke JT, Dollinger MM, Gerken G, Scheulen ME, Wege H, Zagonel V, Cillo U, Trevisani F, Santoro A, Montesarchio V, Malek NP, Holzapfel J, Herz T, Ammendola AS, Pegoraro S, Hauns B, Mais A, Lauer UM, Henning SW, Hentsch B. Resminostat plus sorafenib as second-line therapy of advanced hepatocellular carcinoma - The SHELTER study. J Hepatol. 2016 Aug;65(2):280-8. doi: 10.1016/j.jhep.2016.02.043. Epub 2016 Mar 4. PMID 26952006