Prospective evaluation of image and molecular fingerprint characterization to guide treatment with tyrosine kinase inhibitors in hepatocellular carcinoma

• Conditions: C22.0; Liver cell carcinoma

• Registration Number: DRKS00015917
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-11
• Study Completion: 2023-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1.HCC patients with indication for the treatment with a tyrosine kinase inhibitor (TKI), irrespective of previous systemic therapies.
2.If prior systemic therapies had been applied, progression has to be documented prior to the start of treatment with the TKI.
3.Male or female = 18 years and written informed consent.
4.Histologically confirmed advanced stage hepatocellular carcinoma, BCLC class B or C.
5.Child-Pugh class A or B. Only patients with Child-Pugh index class B of not more than 7 will be included. Patients with untreatable ascites or hepatic encephalopathy > Grade 1 are excluded (see exclusion criteria).
6.ECOG performance status 0, 1 or 2.
7.Life expectancy of 12 weeks or more.
8.At least one measurable lesion without previous local therapy and that is suitable for accurate repeated measurements as per mRECIST guidelines.
9.Adequate hematological parameters, as demonstrated by:
10.Hemoglobin = 9.0 g/dl (SI units: 5.6 mmol/l);
11.WBC = 2.5 x 109/l;
12.Platelets = 60 x 109/l;
13.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 times upper limit of normal range (ULNR);
14.Bilirubin = 3 mg/dl;
15.Serum creatinine = 1.5 mg/dl (SI units: 132 µmol/l);
16.Prothrombin Time (PT) International Normalized Ratio (INR) = 1.5.

Exclusion Criteria

Patients who meet any of the following criteria are not eligible for study participation:
1.Renal failure requiring hemo- or peritoneal dialysis.
2.Patients with no adequate treatment for gastrointestinal bleeding and esophagus varices within 14 days prior to study entry.
3.Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I.
4.Altered mental status precluding understanding of the informed consent process.
5. Pregnancy or breastfeeding mother.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prospectively evaluate clinically available image and / or molecular fingerprint analysis of HCC tumor tissue to predict therapy responses.

Secondary Outcome Measures

Name	Time	Method
•Time needed to determine parameter based prediction of therapy outcome for single parameters and for multiscale modelling.<br>•Progression free survival (PFS).<br>•Radiologically determined time to tumor progression (TTP).<br>•Objective response rate (ORR) as measured by the sum of partial and complete responders.<br>•Duration of tumor stabilization (CR, PR, SD).<br>•Overall survival (OS).<br>•To prospectively assess patient-reported outcome of HCC patients under treatment with sorafenib.<br>•Distribution of sorafenib adverse drug reactions.<br>•Feasibility of circulating miRNA Analysis, radiomics analysis and ultrasound elastography.<br>