Neoplasms

Digestive System Diseases

All Conditions

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.

Microwave ablation

Hyun Hee Lee

Jeong Min Lee, MD, PhD

The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.

Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies

Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study

Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.

Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success

Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation.

Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.

Seoul National University Hospital

Professor

Liver Failure

Hepatic Insufficiency

Mu-xing Li, M.D.

Insufficient future liver remnant (FLR), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. Associating liver partition and portal vein ligation (ALPPS) was introduced to induce rapid and extensive liver hypertrophy, which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient FLR at their first stage operation. Feasibility of the second stage of ALPPS has been assessed mostly on the basis of laboratory parameters and volumetry by the 3D reconstruction of CT. Meanwhile, part of the patients who underwent the second stage ALPPS still experienced postoperative liver failure, even in patients with sufficient FLR volume. In other words, this volumetric increase may not reflect the increase of liver function. And the laboratory parameters can only partly reflect the global liver function but not the regional liver function. Therefore, the combination of volumetric and global liver function tests might be unsuitable for predicting FLR function after first stage ALPPS because function is distributed unequally between left and right liver lobe. The Gd-EOB-DTPA-enhanced liver MRI, which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage ALPPS in one examination. Thus we performed this clinical trial in order to evaluate the efficacy of Gd-EOB-DTPA-enhanced liver MRI in evaluating the FLR liver function after the first stage ALPPS.

The clinical data and follow up information of the patients who underwent laparoscopic ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of the first and second ALPPS was evaluated by multi-disciplinary team (MDT). The liver function evaluation indexes of Gd-EOB-DTPA Enhanced liver MRI such as RE (Relative enhancement of the liver)=（SI20min-SIunenhanced）/ SIunenhanced and other related indexes were calculated. SI referred to signal intensity. SI20 min referred to the signal intensity in the hepatocyte phase (20 min after the injection). The relationship between the indexes and postoperative liver failure as well as other complications were analyzed.

In order to further elucidate the molecular mechanism for the liver hypertrophy induced by the ALPPS, the blood sample and liver tissue sample before the first \& second stage ALPPS operations will be collected under the permission of the patients.

Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI

The "50-50 criteria" was applied to assess post-treatment liver failure, which considers the increased total bilirubin level (\>50 umol/L) and decreased PTA (\<50%) on postoperative day 5.

Postoperative morbidities and mortalities were graded according to the Clavien classification.

Peking University Third Hospital

Antineoplastic Agents

Tislelizumab

Antineoplastic Agents, Immunological

Patients who meet the inclusion criteria will receive ALPPS stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W 6-12 months after stage II surgery.

Patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks after stage I surgery.

In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W 6-12 months after stage II surgery.

In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 4-8 weeks after stage I surgery; In control group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks after stage I surgery.

ALPPS surgery

Lu C Wang, M.D.

Lu Wang, M.D.

Study design: Prospective, single-center, phase IIa clinical trial; Primary endpoint: Recurrence free survival; Secondary endpoints: Safety, overall survival; Main characteristics of patients: Liver malignancy, required (extended) hemihepatectomy, insufficient liver reserve; Study approaches: The experimental group is treated with ALPPS combined with Tislelizumab, and the control group was treated with ALPPS; Sample size: 20 (10:10); Study process: In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W 6-12 months after stage II surgery; In control group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks after stage I surgery.

ALPPS Combined With Tislelizumab in Liver Malignancy

Safety and Efficacy of the Combinationg of Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) and Tislelizumab in Liver Malignancy

incidence of adverse events and serious adverse events

Fudan University

Head of liver surgery department

Rare Diseases

Carcinoma

Sarcoma

Carcinoma, Hepatocellular

Rhabdoid Tumor

Hepatoblastoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Soft Tissue Sarcoma

Embryonal Sarcoma

Morgan Paul, BSN

Daniel Pieratt, MPA

Morgan L Paul, BSN

Rakesh Sindhi, MD

The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

Pediatric liver cancers are rare, affecting at times no more than 1 in one million population. Understanding the molecular basis of these cancers is important in order to develop more accurate diagnoses and more effective treatments. Current classifications of these cancers are based on how these cancers look on diagnostic studies such as radiologic imaging or under the microscope. Such a classification system does not explain why a particular cancer has a different outcome from what is considered "usual" for that particular cancer. Nor does such a classification system explain why two different classes of cancers behave the same way. Understanding the genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

To achieve these goals, large numbers of such cancer patients or affected tissue must be collected. This is not possible in any single institution, or any single country. The current project will collect biological samples such as residual tumor tissue, saliva, or blood from affected patients and their biological parents and families, along with clinical information about the cancer. These biological samples will be used to study the genes and how these genes work in tumor tissue and in non-tumor tissue. The results of this study will permit childhood liver cancers to be categorized on the basis of common defects in genes and their function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies	NCT06426992	Liver Malignant...	Microwave ablat...	20 Years - 85 Years	Seoul National University Hospital
Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI	NCT04559451	Liver Function ... Liver Malignant...		18 Years - 75 Years	Peking University Third Hospital
ALPPS Combined With Tislelizumab in Liver Malignancy	NCT04996446	Liver Malignant...	Tislelizumab ALPPS surgery	18 Years - 70 Years	Fudan University
Molecular Basis of Pediatric Liver Cancer	NCT03959800	Childhood Liver... Liver Malignant... Embryonal Sarco... Hepatoblastoma Hepatocellular ... Rhabdoid Tumor ...		0 Years - 99 Years	University of Pittsburgh
Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI	NCT04559451	Liver Function ... Liver Malignant...		18 Years - 75 Years	Peking University Third Hospital

Spots Global Cancer Trial Database for liver malignant tumors