AzTrials
AzTrials

Hepatocellular Carcinomae:Med-HCC-2NCT03958669

Fingerprint Characterization Tyrosine Kinase Inhibitors in Advanced HCC

An observational study of Hepatocellular Carcinoma and Sorafenib, run by University Hospital Tuebingen at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is a prospective evaluation of a multiscale prediction model for the treatment with tyrosine kinase inhibitors (TKI) in HCC. Patients with HCC that qualify for systemic treatment with TKIs will be included. At baseline, prior to treatment, molecular and image fingerprints are collected (fingerprint #1). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, Sorafenib
How many people
2 participants
Where
1 siteGermany
Study dates
1 Nov 2019to 31 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: We will prospectively enrol all patients with HCC at our institution that qualify for a systemic treatment with sorafenib that fulfil the inclusion and exclusion criteria.

Who may be able to join

  • HCC patients with indication for the treatment with an approved tyrosine kinase inhibitor, irrespective of previous systemic therapies.
  • If prior systemic therapies had been applied, progression has to be documented prior to the start of treatment.
  • Male or female ≥ 18 years and written informed consent.
  • Histologically confirmed advanced stage hepatocellular carcinoma, BCLC class B or C.
  • 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).
  • ECOG performance status 0, 1 or 2.
Show all 16Show fewer
  • Life expectancy of 12 weeks or more.
  • At least one measurable lesion without previous local therapy and that is suitable for accurate repeated measurements as per mRECIST guidelines.
  • Adequate hematological parameters, as demonstrated by:
  • Hemoglobin ≥ 9.0 g/dl (SI units: 5.6 mmol/l);
  • WBC ≥ 2.5 x 109/l;
  • Platelets ≥ 60 x 109/l;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal range (ULNR);
  • Bilirubin ≤ 3 mg/dl;
  • Serum creatinine ≤ 1.5 mg/dl (SI units: 132 µmol/l);
  • Prothrombin Time (PT) International Normalized Ratio (INR) ≤ 1.5.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Eberhard Karls University

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

Official title: Prospective Evaluation of Image and Molecular Fingerprint Characterization to Guide Treatment With Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma

This study is a prospective evaluation of a multiscale prediction model for the treatment with tyrosine kinase inhibitors (TKI) in HCC. Patients with HCC that qualify for systemic treatment with TKIs will be included. At baseline, prior to treatment, molecular and image fingerprints are collected (fingerprint #1). Further fingerprint investigations will be performed after a short treatment period at week 4 (fingerprint #2) and optional at tumor progression (Fingerprint #3). Based on previous findings from a preceding trial the fingerprint diagnostics #1 and #2 will be used to determine a prediction for treatment outcome at the earliest possible point in time ("therapy prediction"). This prediction will be compared to the prospectively determined outcome of the treated patients in this study (validation cohort; primary study endpoint). Fingerprint #3 will be optional to generate hypothesis for treatment failure.

Read the detailed description

The aim of this prospective observational clinical study is to validate prognostic parameters for the treatment with tyrosine kinase inhibitors (TKI) that have been identified in a separate patient cohort with HCC (Study title "Fingerprint characterization of advanced HCC to optimize treatment decisions and enable an early prediction of therapy resistance", ClinicalTrials.gov Identifier NCT02372162). Based on these previous findings, predefined parameters that have been found to correlate with therapy responses will be determined for the patients in this observational trial. Diagnostic procedures include an image fingerprint (MRI and multi-phase CT scan of tumor manifestations, radiomics analysis of defined tumor areas, ultrasound elastography and a molecular fingerprint with exome and transcriptome sequencing from tumor tissue, single cell sequencing of PBMCs, MR spectroscopy for metabolomics analysis of blood and urine. These parameters at baseline will be used to predict therapy outcome, which will be prospectively compared to the clinical outcome under treatment with sorafenib. A second fingerprint will be collected at 4 weeks treatment and optional at tumor progression. New hypothesis generating parameters will be investigated in this patient cohort .

Keywords
Liver Cancer, Imaging, Molecular Charakterization, Tyrosine Kinase Inhibitor
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03958669
Study groupRoleWhat they receive
Sorafenib treated HCC patientsNo intervention is performed. This is an observational study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To prospectively evaluate image fingerprint analysis of HCC tumor tissue to predict therapy responses

    MRI and CT scan, including radiomics analysis

    Measured: 6 months after therapy initiation

  2. To prospectively evaluate molecular fingerprint analysis of HCC tumor tissue to predict therapy responses

    Multiscale analysis of exome, transcriptome and metabolic Tumor characteristics

    Measured: 6 months after therapy initiation

Secondary outcomes (11)

  1. Time needed to determine parameter based prediction of therapy outcome for single parameters and for multiscale modelling

    Days needed for prediction of therapy outcome by image, molecular and metabolic analysis

    Measured: Diagnostic procedures at baseline and between week 3 and 6 after treatment initiation

  2. Progression Free Survival

    Months

    Measured: Median PFS is expected between 3.5 and 5.5 months

  3. Radiologically determined time to tumor progression (TTP)

    Months

    Measured: Median TTP is expected between 3.5 and 5.5 months

  4. Objective response rate (ORR) as measured by the sum of partial and complete responders.

    % of all treated patients

    Measured: Within 6 months after treatment initiation

  5. Duration of tumor stabilization (CR, PR, SD)

    Days of duration of CR, PR or SD after diagnosis of best response

    Measured: Through study completion, up to 18 months

  6. Overall Survival (OS)

    Months

    Measured: Current data suggest approximately 12 months

  7. To prospectively assess patient-reported outcome of HCC patients under treatment with sorafenib

    EORTC QLQ-C30 questionnaire

    Measured: Through study completion, up to 18 months

  8. Distribution of sorafenib adverse drug reactions

    CTCAE criteria

    Measured: Through study completion during sorafenib treatment, up to 18 months

  9. Feasibility of detection of circulating miRNA

    Change of miRNA detection in peripheral blood sample between baseline and after treatment initiation

    Measured: Baseline and between week 3 and 6 after treatment initiation

  10. Changes of Radiomics analysis under treatment with Sorafenib

    Collection of radiomics features of tumor tissue at baseline and after treatment initiation

    Measured: Baseline and between week 3 and 6 after treatment initiation

  11. Changes of ultrasound elastography under treatment with Sorafenib

    Determination of ultrasound elastography of tumor tissue at baseline and after treatment initiation

    Measured: Baseline and between week 3 and 6 after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start1 Nov 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 May 2023

Why it stopped: Slow recruitment due to COVID-19 pandemic and several newly approved treatment options

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03958669
Sponsor's protocol ID
e:Med-HCC-2
Acronym
e:Med-HCC-2
Status last verified
Mar 2024
First submitted
16 Dec 2018
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma and Sorafenib, run by University Hospital Tuebingen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow recruitment due to COVID-19 pandemic and several newly approved treatment options). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To prospectively evaluate image fingerprint analysis of HCC tumor tissue to predict therapy responses (time frame: 6 months after therapy initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03958669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in