Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization

Hepatocellular Carcinoma Non-resectable Clinical Trial

— Mona-Lisa  

Official title:

Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390112
• Other study ID #: 2019/330/OB
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Rouen
• Contact: Vincent VERDIER, MD
• Phone: +33 2 32 88 86 10
• Email: vincent.verdier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE

Description:

The incidence of hepatocellular carcinoma (HCC) has increased significantly over the past 30 years.

The majority of HCCs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of Transarterial chemoembolization (TACE). This treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. This evaluation is currently based on imaging performed at one month (M1) (MRI and/or CT scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (M1) the treatment. However, these evaluation tools have many limitations and remain imperfect in predicting response to treatment.

In this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. It is characterized by the detection of tumor elements in the bloodstream such as circulating tumor DNA (ctDNA). Several studies have successfully demonstrated the diagnostic or prognostic value of ctDNA in patients followed for HCC.

the aim of our study is to evaluate the impact of ctDNA detection in the follow-up of patients treated by TACE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal, and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.

• Histologically diagnosed HCC in the absence of an imaging diagnosis

• Patient with a first TACE (naive) or not, regardless of the number of previous procedures

• Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.

• Treatment decision validated by the digestive oncology staff.

• Patient having read and understood the information letter and signed the informed consent.

• Patient follow-up performed at the Charles Nicolle University Hospital in Rouen.

Exclusion Criteria :

• Other active cancer or hematological malignancy, currently being treated

• Patient not affiliated to the social security system

• Pregnant woman or woman in labour or breastfeeding

• Person deprived of liberty by an administrative or judicial decision

• Person placed under court protection

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Circulating Tumor DNA
• Hepatocellular Carcinoma Non-resectable
• Transarterial Chemoembolization

Intervention

Biological:
• DNA
ctDNA; cfDNA

Locations

Country	Name	City	State
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological response at 1 month according to mRECIST and ctDNA detection	radiological response : mRECIST (progressive disease; stable disease, partial response, complete response) LIRADS (LR-TR Nonviable, LR-TR Equivocal, LR-TR Viable); ctDNA at 1 month detection (yes or no)	4 to 6 weeks
Secondary	Progression-free survival and overall survival	progression-free Survival and overall Survival (months)	4 to 6 weeks