Clinical Trials Logo

Clinical Trial Summary

Percutaneous thermal ablation (PTA), resection and liver transplantation (LT) are the standard curative options for hepatocellular carcinoma (HCC). LT yields the best long-term outcomes but is limited by graft shortage. Thus, patients with ≤3cm HCC are mainly treated by PTA although recurrence is frequent and may occur outside transplant criteria. However, data on non transplantable recurrence (NTR) following PTA are lacking. Therefore, the investigators investigated the incidence and predictors of NTR among transplantable patients with ≤3cm HCC(s) treated by PTA, in order to stratify them according to their NTR risk and to improve treatment allocation.

Clinical Trial Description

Consecutive patients undergoing PTA for HCC between January 2015 and December 2020 were included. Data were collected from our prospective database. This study was approved by our institutional review board (NCT03428321 []) and written informed consent was obtained from all patients. Inclusion criteria were: HCC diagnosed by histopathology or by EASL imaging criteria, HCC ≤30mm, 1 - 3 tumor nodules, follow-up<3 months, no prior or combined treatment with intra-arterial therapy, potentially transplantable patient (ie, ≤70yr, AFP-score≤2 (7), no macroscopic portal vein invasion or extra-hepatic metastasis, no major comorbidity precluding LT). Patient's and liver's characteristics were collected including: age, sex, HCC-naïve status, body mass index (BMI), diabetes mellitus, liver steatosis, cirrhosis, cause for hepatopathy, AFP serum level, Child-Pugh, MELD and Albumin-Bilirubin (ALBI) scores and preablative biological data. Occurrence of NTR after PTA will be analyzed in a competing risks framework, with transplantation and death as competing events. Covariates associated with NTR were analyzed using Fine-Gray proportional sub-distribution hazards models. Recurrence-free survival (RFS) will be defined as the time from PTA until the first recurrence, death, or last follow-up. OS will be defined as the interval between PTA and death (any cause) or last follow-up. Survival curves will be estimated using the Kaplan-Meier method and compared with the log-rank test. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05202184
Study type Observational
Source University Hospital, Montpellier
Status Completed
Start date January 1, 2015
Completion date December 30, 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05458115 - Clinical Study of MRD Recurrence Monitoring After Surgical Resection of Hepatocellular Carcinoma
Not yet recruiting NCT05022628 - Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis Phase 4
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Recruiting NCT04542837 - The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma Phase 2
Not yet recruiting NCT05025592 - cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
Completed NCT04172506 - A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT02785874 - Statin With Palliative Therapy for HCC N/A
Not yet recruiting NCT02715492 - Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma. Phase 3
Completed NCT02985034 - Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT N/A
Recruiting NCT05581004 - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Suspended NCT02935478 - Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation N/A
Recruiting NCT05592171 - Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCC N/A
Completed NCT03176485 - Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors N/A
Recruiting NCT05544253 - Safety and Efficacy of Mitomycin C-based HIPEC After srHCC and PM of HCC Phase 2/Phase 3
Completed NCT02675920 - A Study of HCC High Risk Group Using Two Surveillance Tools
Completed NCT02833298 - Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening N/A
Active, not recruiting NCT04588051 - Cabozantinib in Hepatocellular Carcinoma Phase 2
Not yet recruiting NCT03314532 - The Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma N/A
Recruiting NCT03097848 - Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma N/A
Completed NCT03045445 - "Double Low-Dose" DECT for HCC Imaging N/A