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Fingerprint Characterization of Advanced HCC (e:Med-HCC-1)

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ClinicalTrials.gov Identifier: NCT02372162
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Michael Bitzer, University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Other: Image Fingerprint Other: Molecular Fingerprint

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.


Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Fingerprint Characterization of Advanced HCC to Optimize Treatment Decisions and Enable an Early Prediction of Therapy Resistance (HCC Multiscale Trial-1)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Group/Cohort Intervention/treatment
Group A - TACE
Patients with transarterial chemoembolization (TACE) will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo.
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
Group B - Sorafenib
Patients with Sorafenib treatment will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo.
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



Primary Outcome Measures :
  1. Availability of comprehensive imaging and molecular fingerprint data of individual tumors [ Time Frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months ]
    The aim of this feasibility study is to get comprehensive image and molecular fingerprints of individual tumors that can be used for systems biology approaches to predict therapy outcome and govern therapeutic decisions.


Secondary Outcome Measures :
  1. Determination of turnaround time for image and molecular data availability [ Time Frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months ]
    To set-up and optimize the workflow of data gathering and analysis for molecular and image fingerprints.

  2. Description of correlations between image and molecular data [ Time Frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months ]
    Correlation of results from image and molecular fingerprints at one point of time

  3. Description of correlations between image and molecular data [ Time Frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months ]
    Correlation of either image or molecular fingerprints at three different time points

  4. Identification of molecular and image patterns of treatment failure [ Time Frame: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months ]
    To identify molecular and image patterns of early treatment failure.

  5. Identification of molecular and image patterns of treatment success [ Time Frame: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months ]
    To identify molecular and image patterns of early treatment success

  6. Comparison of molecular and image pattern fingerprints in patients and animal models [ Time Frame: Evaluation within 48 months ]
    To compare molecular and image patterns from HCC patients with respective patterns from different animal models which might identify suitable preclinical models for different clinical tumor patterns.

  7. Identification of early outcome prediction patterns [ Time Frame: Evaluation within 48 months ]
    To determine ideal imaging methods for an early prediction of progressive disease

  8. To provide data for a molecular diagnostic board [ Time Frame: Each individual patient will be evaluated as soon as data sets are available within this feasibility study ]
    To set up a molecular diagnostic board that checks for data-based tailored treatment options

  9. Biomarker analysis [ Time Frame: Evaluation within 48 months ]
    To identify clinical relevant biomarkers from tumor tissue or blood / urine analysis


Biospecimen Retention:   Samples With DNA
Biospecimens that will be investigated are tumor tissue and blood.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients aged ≥ 18, of both genders, with advanced stage hepatocellular carcinoma, for Group A BCLC class B (intermediate stage, performance status-ECOG 0, multinodular HCC), for Group B BCLC class B or C (advanced stage, performance status-ECOG 1-2, invasive tumor pattern (vascular invasion/extra hepatic spread)).

Number: Up to 20 patients to receive therapy with TACE (Group A) and up to 20 patients to receive Sorafenib as first-line systemic therapy (Group B).

Criteria

Inclusion Criteria:

All inclusion criteria must be met at the time of screening unless otherwise specified:

  1. Male or female ≥ 18 years.
  2. Written informed consent obtained prior to any trial specific procedure.
  3. Advanced stage hepatocellular carcinoma, BCLC class B for Group A and BCLC class B or C for Group B (refer to Appendix 3 for BCLC classification).
  4. Child-Pugh class A and 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; (refer to Appendix 4 for Child Pugh classification)).
  5. Indication for TACE or sorafenib treatment confirmed by an interdisciplinary tumor board.
  6. ECOG performance status 0, 1 or 2 (refer to Appendix 2 for definitions of ECOG grades).
  7. Life expectancy of 12 weeks or more.
  8. Adequate hematological parameters, as demonstrated by:

    • Hemoglobin ≥ 9.0 g/dl (SI units: 5.6 mmol/l);
    • WBC ≥ 3.0 x 109/l;
    • Absolute neutrophil count ≥1,500/mm3;
    • Platelets ≥ 75 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;
    • Serum potassium, magnesium and calcium within normal range.
  9. Safe contraception in females of childbearing potential during the entire study using an established treatment with hormonal contraceptives for at least 2 months prior to start of screening.
  10. For females of child bearing potential (without using hormonal contraceptives for at least 2 months prior to start of screening) a double contraception method is requested during the entire study meeting the criteria for an effective method of birth control. That means at least two effective birth control methods such as condoms, diaphragms or intra-uterine devices must be used.
  11. Male patients with partners of child bearing potential are requested to use barrier contraception in addition to having their partner use another method of contraception during the trial and for 3 months after the last dose. Male patients will also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.
  12. Able to comply with all the requirements of the protocol.

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. Known central nervous system (CNS) tumors including symptomatic brain metastasis.
  3. Patients with no adequate treatment for gastrointestinal bleeding and esophagus varices within 14 days prior to study entry.
  4. Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I (see Child-Pugh index, Appendix 4).
  5. History and current cardiovascular complications, including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, a condition requiring anti arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
  6. Current evidence of any severe internal, psychiatric or neurologic disease.
  7. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.
  8. Pregnant or breastfeeding women.
  9. Active alcohol and/or drug abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372162


Locations
Germany
University Hospital
Tuebingen, BW, Germany, D-72076
Sponsors and Collaborators
University Hospital Tuebingen
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Michael Bitzer, MD University Clinic, Eberhard Karls University, Tübingen, Germany

Additional Information:
Responsible Party: Prof. Michael Bitzer, Deputy Director Department of Gastroenterology, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02372162     History of Changes
Other Study ID Numbers: e:Med Tuebingen, Protocol #1
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Prof. Michael Bitzer, University Hospital Tuebingen:
Hepatocellular Carcinoma
Molecular Diagnostics
Sorafenib
Therapeutic chemoembolization
Next-generation sequencing
Sequence analysis, DNA
Sequence analysis, RNA
Metabolomics

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action