Analysis of cfDNA in Patients With Hepatocarcinoma and Treated by Sorafenib or Regorafenib

NCT03956940 | Terminated

• 1 other identifier: 2018-A02911-54
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this trial is to investigate whether quantitative analysis of the total concentration of circulating free deoxyribonucleic acid (cfDNA) and of the cfDNA integrity index (DII) (Intplex®) may reflect hepatocellular carcinoma (HCC) tumor dynamics or response for patients treated by Sorafenib or Regorafenib and if it could be used as a tool for patient management under targeted therapy.

Conditions

Hepatocarcinoma

Keywords

Hepatocarcinoma; cfDNA; intplex

Outcome Measures

Primary Outcomes (1)

• Detection rate of total circulating free deoxyribonucleic acid (cfDNA) concentration at the baseline.

  Total cfDNA concentration is considered as detected if total cfDNA concentration ≥ 5 ng/mL and not detected if total cfDNA concentration \< 5 ng/mL

  Baseline

Secondary Outcomes (6)

• total circulating free deoxyribonucleic acid (cfDNA) fragmentation index

  Baseline

• Objective response rate

  Approximately 36 months

• Disease control rate

  Approximately 36 months

• Progression-Free Survival

  Approximately 36 months

• Time-to-progression

  Approximately 36 months

Study Arms (1)

Intplex test

EXPERIMENTAL

In vitro diagnostic device

Device: Intplex test

Interventions

Intplex test DEVICE

Blood sample at baseline, 15 days, 4-8-16 weeks and then every 12 weeks

Intplex test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age
• Histological or cytological documentation of hepatocellular carcinoma (HCC) or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis
• Patient treated for stage B hepatocellular carcinoma (multifocal disease) or stage C (metastatic disease) according to Barcelona Clinic liver cancer, regardless of treatment line, and that cannot benefit from local treatments such as resection, local ablation, chemoembolization
• At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST criteria 1.1 and modified RECIST for HCC
• Liver function status Child-Pugh Class A
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
• Hemoglobin \> 8.5 g/dL
• Absolute neutrophil count ≥ 1500/mm3
• Platelet count ≥ 60,000/ mm3
• Total bilirubin ≤ 2 mg/dL
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 x Upper limit normal (ULN)
• Lipase ≤ 2 x ULN
• Prothrombin time-international normalized ratio (PT-INR) \< 2.3 x ULN and partial thromboplastin time (PTT) \< 1.5 x ULN

You may not qualify if:

• Prior liver transplantation or candidates for liver transplantation
• Hypersensitivity to the active substance or to any of the excipients
• Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention
• Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or non-melanoma skin cancer and superficial bladder tumors. Any cancer curatively treated \> 3 years prior to study entry is permitted
• Known history or symptomatic metastatic brain or meningeal tumors
• Major surgical procedure or significant traumatic injury within 28 days before enrollment
• Congestive heart failure New York Heart Association (NYHA) ≥ class 2
• Unstable angina or myocardial infarction within the past 6 months before enrollment
• Cardiac arrhythmias requiring anti-arrhythmic therapy
• Uncontrolled hypertension
• Patients with phaeochromocytoma
• Uncontrolled ascites
• Persistent proteinuria of NCI-CTCAE version 4.0 ≥ Grade 3
• Ongoing infection \> Grade 2 according to NCI-CTCAE version 4.0. Hepatitis B is allowed if no active replication is required
• Clinically significant bleeding NCI-CTCAE version 4.0 ≥ Grade 3 within 30 days before enrollment

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (6)

Hôpital Saint-Eloi

Montpellier, Hérault, 34295, France

Location

CHU Grenoble - Hôpital Michalon

Grenoble, Isère, 38043, France

Location

Hôpital Hôtel Dieu

Nantes, Loire-Atlantique, 44093, France

Location

CHRU Nancy - Hôpital Brabois

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511, France

Location

CHRU de Lille - Hôpital Claude Duriez

Lille, Nord, 59037, France

Location

Hôpital Beaujon

Clichy, Seine-Saint-Denis, 92210, France

Location

Related Publications (15)

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• Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouilleres O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including alpha-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Eric ASSENAT, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 21, 2019
• Study Start: October 4, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)