Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05390112
Other study ID # 2019/330/OB
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04592029 - TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC Phase 1
Recruiting NCT05953337 - Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC) N/A
Not yet recruiting NCT03283956 - Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan N/A
Recruiting NCT03652467 - The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma Phase 1
Recruiting NCT05031949 - Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma Phase 1
Completed NCT03533920 - Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma N/A
Recruiting NCT05992220 - Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion Phase 2
Not yet recruiting NCT05057104 - Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
Completed NCT04599777 - TACE Combined With Sorafenib and Tislelizumab for Advanced HCC Phase 2
Completed NCT04599790 - TACE Combined With Lenvatinib and Sintilimab for Advanced HCC Phase 2
Recruiting NCT02967887 - Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC Phase 2
Recruiting NCT05608213 - Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC Phase 3
Recruiting NCT05608200 - Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC Phase 3
Completed NCT04926376 - Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC N/A
Recruiting NCT06133062 - Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma Phase 2
Completed NCT02989922 - A Study to Evaluate SHR-1210 in Subjects With Advanced HCC Phase 2
Recruiting NCT04273100 - PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC Phase 2
Completed NCT06408753 - Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT
Withdrawn NCT03563170 - QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine Phase 1/Phase 2
Recruiting NCT05713994 - Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma