Clinical trial · Observational
GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start
Non Interventional Study in Patients With Diagnosis of HCC in Whom a Decision to Treat With Sorafenib Has Not Been Made at Time of Study Enrollment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is officially cancelled bevore FPFV.
Summary
Brief summary (as posted)
This study is an international prospective, open-label, multi-center, non-interventional study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment. All patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. Detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Any treatment for unresectable HCC as chosen by the physician | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Any treatment for unresectable HCC as chosen by the physician
Primary outcomes (2)
- measure
- Determination of 'real-life' practice patterns of physicians involved in the care of patients with HCC (collection of data on treatments prescribed as well as demographic data and data on the entire medical history)
- timeFrame
- up to 3,3 years
- measure
- Evaluation of patient demographics, disease characteristics, methods of patient evaluation, diagnosis and follow-up of patients with HCC, regionally and globally (collection of data on demographics, medical history, diagnostic measurements, follow-up)
- timeFrame
- up to 3,3 years
Secondary outcomes (5)
- measure
- Evaluation of natural course and outcomes of patients with HCC (collection of data of disease status during the course of the study and the outcome of treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Outpatients with histologically/cytologically documented or radiographically diagnosed HCC in whom a decision to treat with sorafenib has not been made at this time. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI. * Patients must have signed an informed consent form * Patients must have a life expectancy of at least 8 weeks Exclusion Criteria: * Patients in whom a decision to treat with sorafenib is made at time of study start * Patients who have received sorafenib in the past or are currently treated with sorafenib * Hospice patients
References
Publications (0)
Data not yet available