Hepatocellular Carcinoma Clinical Trial
— e:Med-HCC-2Official title:
Prospective Evaluation of Image and Molecular Fingerprint Characterization to Guide Treatment With Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma
NCT number | NCT03958669 |
Other study ID # | e:Med-HCC-2 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | May 31, 2023 |
Verified date | March 2024 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | May 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. HCC patients with indication for the treatment with an approved tyrosine kinase inhibitor, irrespective of previous systemic therapies. 2. If prior systemic therapies had been applied, progression has to be documented prior to the start of treatment. 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. |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Eberhard Karls University | Tübingen | BW |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | German Federal Ministry of Education and Research |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To prospectively evaluate image fingerprint analysis of HCC tumor tissue to predict therapy responses | MRI and CT scan, including radiomics analysis | 6 months after therapy initiation | |
Primary | To prospectively evaluate molecular fingerprint analysis of HCC tumor tissue to predict therapy responses | Multiscale analysis of exome, transcriptome and metabolic Tumor characteristics | 6 months after therapy initiation | |
Secondary | 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 | Diagnostic procedures at baseline and between week 3 and 6 after treatment initiation | |
Secondary | Progression Free Survival | Months | Median PFS is expected between 3.5 and 5.5 months | |
Secondary | Radiologically determined time to tumor progression (TTP) | Months | Median TTP is expected between 3.5 and 5.5 months | |
Secondary | Objective response rate (ORR) as measured by the sum of partial and complete responders. | % of all treated patients | Within 6 months after treatment initiation | |
Secondary | Duration of tumor stabilization (CR, PR, SD) | Days of duration of CR, PR or SD after diagnosis of best response | Through study completion, up to 18 months | |
Secondary | Overall Survival (OS) | Months | Current data suggest approximately 12 months | |
Secondary | To prospectively assess patient-reported outcome of HCC patients under treatment with sorafenib | EORTC QLQ-C30 questionnaire | Through study completion, up to 18 months | |
Secondary | Distribution of sorafenib adverse drug reactions | CTCAE criteria | Through study completion during sorafenib treatment, up to 18 months | |
Secondary | Feasibility of detection of circulating miRNA | Change of miRNA detection in peripheral blood sample between baseline and after treatment initiation | Baseline and between week 3 and 6 after treatment initiation | |
Secondary | Changes of Radiomics analysis under treatment with Sorafenib | Collection of radiomics features of tumor tissue at baseline and after treatment initiation | Baseline and between week 3 and 6 after treatment initiation | |
Secondary | Changes of ultrasound elastography under treatment with Sorafenib | Determination of ultrasound elastography of tumor tissue at baseline and after treatment initiation | Baseline and between week 3 and 6 after treatment initiation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |