NCT03140332: HCC-CTPerf

Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.

Completed NA Last updated 20 July 2020

What this trial tests

NA trial testing Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib in Hepatocellular Carcinoma in 2 participants. Completed in 27 February 2020.

Timeline

27 February 2017

Primary endpoint
27 February 2020

27 February 2020

Quick facts

Lead sponsor	Centre Hospitalier Universitaire, Amiens
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	2
Start date	27 February 2017
Primary completion	27 February 2020
Estimated completion	27 February 2020
Sites	1 location across France

Drugs / interventions tested

• Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
• Perfusion Scanner — all drugs for Perfusion Scanner →

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, any sex, with Hepatocellular Carcinoma or Perfusion Scanner. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response.

This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival.

Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.