CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

Valérie LAURENT9 enrolled

Overview

The purpose of this study is to compare CT perfusion parameters to RECIST 1.1 and mRECIST assessment for advanced HCC treated by systemic immunotherapy, and to evaluate perfusion parameters as predictive factors of response on baseline and on early follow-up

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced HCC Treated by Systemic Immunotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients \> 18 years old * Proved HCC * Advanced HCC, defined as Barcelona Clinic Liver Classifications (BCLC) stage B non eligible for loco-regional therapy and stage C * No prior systemic therapy * Measurable disease per Response Evaluation Criteria for Solid Tumour (RECIST) v1.1 * Child-Pugh Score = A * Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2 Exclusion Criteria: * Absence of CT perfusion before treatment initiation more than a two-month delay between treatment initiation and first post-treatment CT perfusion * Uninterpretable CT perfusion * Definitive contraindication to CT perfusion (allergy or advanced renal disease)

Locations (1)

CHRU Nancy

Nancy, France

Outcomes

Primary Outcomes

Comparison of CT perfusion parameters between the responders and non-responders according to RECIST 1.1 assessment for advanced HCC treated by systemic immunotherapy

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test.

Time frame: Through study completion, an average of 1 year

Comparison of CT perfusion parameters between the responders and non-responders according to mRECIST assessment for advanced HCC treated by systemic immunotherapy

modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test.

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Evaluation of CT perfusion parameters as predictive factors of response on baseline and on early follow-up

Assessed using logistic regression

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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