NCT02372162

Fingerprint Characterization of Advanced HCC

Fingerprint Characterization of Advanced HCC to Optimize Treatment Decisions and Enable an Early Prediction of Therapy Resistance (HCC Multiscale Trial-1)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single center, open-label, uncontrolled, non-randomized observational study in patients with advanced HCC. The patients qualify either to a local treatment with transarterial chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib. The aim of this feasibility study is to get a comprehensive image and molecular fingerprint of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve the care of patients that get progressive disease under treatment, the investigators have to improve the investigators understanding of the development of therapy resistance, which will improve patient care at the time point of progressive disease. Therefore, the data of 20 patients in each group will be used to identify molecular and / or image patterns, that can be used to predict treatment responses and thus govern an optimized individual cancer treatment for patients with advanced HCC.

Detailed description

A single-center, open-label, uncontrolled, non-randomized clinical trial. The two treatment groups to receive: Group A Transarterial Chemoembolization (TACE): 20 patients that are treated with TACE will get an image and molecular fingerprint of the tumor prior to the first treatment with TACE, a second image fingerprint between week 2 - 4 after the first treatment with TACE, and a third image and molecular fingerprint at the time point of progressive disease. Group B Sorafenib: 20 patients that are treated with Sorafenib will get an image and molecular fingerprint of the tumor prior to the first treatment, between week 2 and 3 after the start of treatment and at the time point of progressive disease.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
OTHER	Image Fingerprint	This is an observational study that uses in depth diagnostic procedures to characterize patients with a comprehensive Image Fingerprint that includes CT, MRI and PET diagnostics
OTHER	Molecular Fingerprint	This is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-02-26
• Last updated: 2019-06-19

Locations

1 site across 1 country: Germany