NCT02372162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3.9 years

First QC Date

October 9, 2014

Last Update Submit

June 18, 2019

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular CarcinomaMolecular DiagnosticsSorafenibTherapeutic chemoembolizationNext-generation sequencingSequence analysis, DNASequence analysis, RNAMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Availability of comprehensive imaging and molecular fingerprint data of individual tumors

    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.

    Each patient will be evaluated within six months, the whole study outcome will need 48 months

Secondary Outcomes (9)

  • Determination of turnaround time for image and molecular data availability

    Each patient will be evaluated within six months, the whole study outcome will need 48 months

  • Description of correlations between image and molecular data

    Each patient will be evaluated within six months, the whole study outcome will need 48 months

  • Description of correlations between image and molecular data

    Each patient will be evaluated within six months, the whole study outcome will need 48 months

  • Identification of molecular and image patterns of treatment failure

    Each individual patient will be evaluated within six months, the whole study outcome will need 48 months

  • Identification of molecular and image patterns of treatment success

    Each individual patient will be evaluated within six months, the whole study outcome will need 48 months

  • +4 more secondary outcomes

Study Arms (2)

Group A - TACE

Patients with transarterial chemoembolization (TACE) will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo.

Other: Image FingerprintOther: Molecular Fingerprint

Group B - Sorafenib

Patients with Sorafenib treatment will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo.

Other: Image FingerprintOther: Molecular Fingerprint

Interventions

Image FingerprintOTHER

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

Group A - TACEGroup B - Sorafenib
Molecular FingerprintOTHER

This is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing

Group A - TACEGroup B - Sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Male or female ≥ 18 years.
  • Written informed consent obtained prior to any trial specific procedure.
  • 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).

You may not qualify if:

  • Indication for TACE or sorafenib treatment confirmed by an interdisciplinary tumor board.
  • ECOG performance status 0, 1 or 2 (refer to Appendix 2 for definitions of ECOG grades).
  • Life expectancy of 12 weeks or more.
  • 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.
  • 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.
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens that will be investigated are tumor tissue and blood.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Michael Bitzer, MD

    University Clinic, Eberhard Karls University, Tübingen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director Department of Gastroenterology

Study Record Dates

First Submitted

October 9, 2014

First Posted

February 26, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

DE(1)