Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Recurrence

Liver Diseases

Liver Cirrhosis

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Chronic Graft Versus Host Disease

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI).

Radiofrequency ablation will be performed by using triple cooled-wet electrodes. Two or three electrodes will be places around the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF, bipolar mode and switching monopolar mode) will be applied to two of three electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C.

Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes

Hyun Hee Lee

Jae Hyun Kim

Jeong Min Lee, MD, PhD

To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes

No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes

No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes

Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level

Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level

Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 3 mm on 1 month follow-up CT.

Evaluate overall survival by available clinical information and follow-up

Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging.

RF medical

Seoul National University Hospital

Professor

Antineoplastic Agents

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

240mg,ivgtt, every three weeks as a cycle, the first day of each cycle.

toripalimab

12mg (weight ≥60kg) or 8mg (weight \<60kg) orally, once a day

ultrasound-guided percutaneous radiofrequency ablation of recurrent hepatocellular carcinoma

Radiofrequency ablation

Jinxue Zhou, MD

Zhengzheng Wang, MM

This study is a multi-center, prospective, single-arm, open-design phase II clinical study, mainly to explore the clinical effectiveness and safety of radiofrequency ablation combined with anti-PD-1 antibody toripalimab and lenvatinib in patients with short-term recurrence of hepatocellular carcinoma.

Primary endpoint: Recurrence-free survival time (RFS). Secondary endpoints: safety (incidence of adverse events); time to recurrence (TTR); time to local recurrence (TTLR); 12-month recurrence-free survival rate; overall survival (OS); 12 months and 24 Month overall survival rate.

Treatment plan: Patients undergo radiofrequency ablation, 3-5 days after radiofrequency ablation, lenvatinib 12 mg (body weight ≥ 60 kg) or 8 mg (body weight \<60 kg) orally, once a day; toripalimab is a fixed dose of 240 mg, once every 3 weeks, intravenous infusion on the first day of each cycle, the infusion time is no less than 60 minutes.Combination therapy until tumor recurrence, disease progression, death or intolerable toxicity occurs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes	NCT05449873	Recurrent Hepat... Chronic Liver D...	Radiofrequency ...	20 Years - 85 Years	Seoul National University Hospital
Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.	NCT05162898	Recurrent Hepat...	toripalimab Lenvatinib Radiofrequency ...	18 Years - 75 Years	Henan Cancer Hospital
Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.	NCT05162898	Recurrent Hepat...	toripalimab Lenvatinib Radiofrequency ...	18 Years - 75 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for recurrent hepatocellular cancer