Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

Stereotactic ablative radiotherapy (SABR)

Re-transcatheter arterial chemoembolization (re-TACE)

Patients with HCC after incomplete TACE are randomized to stereotactic ablative radiotherapy (SABR). SABR will be delivered in 5 fractions.The preferred inter-fraction time interval is 48 hours. The entire treatment with 10 days is preferred.

Patients with HCC after incomplete TACE are randomized to further re-TACE.

Re-Transcatheter arterial chemoembolization (re-TACE)

Shih-Kai Hung, PhD

Liang-Cheng Chen, MD

Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in treating hepatocellular carcinoma patients with unresectable intermediate stage. However, residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be potentially useful for curatively managing early-stage HCC in retrospective studies. Thus, conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE residual tumors is therefore encouraged. The present phase-III trial intended to compare clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with post-prior-TACE residual tumors.

Developing effective treatment modalities is crucial in managing HCC patients with unresectable intermediate stage. Nowadays, many therapies have been used for treating this group of HCC patients, including TACE. However, residual tumors after TACE are not uncommon. In conventional, re-TACE is recommended for managing residual tumors. However, accumulated overall survival is still poor in consecutive TACEs, leading to a low rate of \<20% in 5 years.

In this regard, radiotherapy has been proved to be effective in managing HCC patients, especially a novel technique named SABR. When compared with conventional-fractionated radiotherapy, SABR demonstrated better treatment responses with fewer side effects in managing primary or metastatic liver tumors. In the literature, phase I and II trials of TACE plus SABR showed excellent local control rates and promising 1- and 2-year survival rates. However, till now, there is no head-to-head comparison between TACE + SABR and consecutive TACEs.

Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)

Comparing Re-trans-catheter Arterial Chemoembolization Versus Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma Patients Who Had Incomplete Response After Prior TACE (TASABR Trial): a Randomized Controlled Trial

The freedom from local progression is defined as no in-field progressive disease. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

To estimate the rates of overall survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

To estimate the rates of progression-free survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

To estimate the response rate. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

The duration of the response is from the time response is achieved until disease progression is detected. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

To estimate the rate of acute and late treatment-related toxicity related to specific symptoms

Buddhist Tzu Chi General Hospital

Hualien Tzu Chi General Hospital

Dalin Tzu Chi General Hospital

Hematinics

Anti-Infective Agents

Liver Extracts

Interferons

Antiviral Agents

Transcatheter Arterial Chemoembolization (TACE)

Transcatheter Arterial Pegylated Interferon Embolization (TAIE)

Man Fung Yuen, Prof

Ching Lung Lai, Prof

Clara Ooi, Prof

Primary: To compare the efficacy of TACE and TAIE.

Secondary: To compare the side effects of TACE and TAIE.

The outcome measurements include survival benefit and tumour regression induced by the two therapies.

A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer

A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma

Schering-Plough

Hospital Authority, Hong Kong

Heart and Blood Diseases

Thrombosis

Micronutrients

Bevacizumab

Atezolizumab

Iodine

Cadexomer iodine

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Immunologic Factors

TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.

Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.

TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.

TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Iodine125 seed implantation into the PVTT was conducted 3-7 days after TACE when the results of the liver function tests were comparable to those obtained before TACE. Pre-procedural planning was conducted using a three-dimensional conformal radiation therapy treatment planning system (TPS) to determine the number of Iodine125 seeds required, the target location for implantation, the best percutaneous puncture site and the access route. The targeted zone for implantation was the tumour thrombosis in the segmental portal vein, left/right portal vein. Implantation was guided by CT, and the Iodine125 seeds were implanted into the PVTT using 18 G needles and the implantation gun that housed the Iodine125 seeds in the cartridge chamber.

I-125 Seeds Brachytherapy in PVTT

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).

Transcatheter arterial chemoembolization

Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .

Atezolizumab plus Bevacizumab

Mingsheng Huang, M.D. & Ph.D.

Luwen Mu, M.D.

The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).

This is a multicenter, open-label trial, randomized controlled to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT. 234 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-AB-I or TACE-AB using a 1:1 randomization scheme. TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-AB-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 3-7 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

This is a multicenter, open-label trial, randomized controlled trial to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT.

TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT

TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial

Time from randomization to death from any cause.

Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.

The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).

The time from randomization until the date that complete portal vein occlusion was confirmed (if the portal vein is patent at diagnosis).

Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

Sun Yat-sen University

Fifth Affiliated Hospital, Sun Yat-Sen University

Second Affiliated Hospital of Guangzhou Medical University

Maoming People's Hospital

Shandong Provincial Third Hospital

Third Affiliated Hospital, Sun Yat-Sen University

The director of Department of Interventional Radiology

Fluorouracil

Ethiodized Oil

Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least.

After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least.

Transcatheter Arterial Chemoembolization (TACE):

5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml,the perfusion time should not be less than 20 min

Transcatheter Arterial Chemoembolization (TACE):

5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml, the perfusion time should not be less than 20 min

DC-CIK:

8×10\^9 DC-CIK cells for each infusion, IV (in the vein) for each infusion at least 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32

DC-CIK

Xiangzhong Liu, Professor

Evaluation of DC-CIK cells combined TACE treatment for HCC

60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.

DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma

Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma

Yantai City Hospital for Infectious Diseases

Shenzhen Hornetcorn Bio-technology Company, LTD

Lenvatinib

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

The goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.

Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

Prediction of Microvascular Invasion by Radiomics Based on Pre-treatment Magnetic Resonance Imaging (MRI) for Guiding Treatment of Barcelona Clinic Liver Cancer (BCLC) Stage B Hepatocellular Carcinoma (HCC): A Prospective Cohort Study

OS was defined as the interval from the date of enrollment to the date of death due to any cause or last follow-up.

PFS was defined as the interval from the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever occurred first.

Assessed by enhanced CT or MR at baseline, every 6 weeks after treatment initiation, using RECIST 1.1 The assessment of tumor response was performed independently by two experienced radiologists who were blinded to the patient's clinical information, and any inconsistent assessment results were resolved by further consensus.

The severity of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)	NCT02921139	Hepatocellular ...	Stereotactic ab... Re-Transcathete...	20 Years -	Dalin Tzu Chi General Hospital
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer	NCT00563095	Carcinoma, Hepa...	Transcatheter A... Transcatheter A...	18 Years -	Hospital Authority, Hong Kong
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT	NCT05984511	Hepatocellular ... Hepatic Portal ... Tumor Thrombus	I-125 Seeds Bra... Transcatheter a... Atezolizumab pl...	18 Years - 75 Years	Third Affiliated Hospital, Sun Yat-Sen University
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer	NCT00563095	Carcinoma, Hepa...	Transcatheter A... Transcatheter A...	18 Years -	Hospital Authority, Hong Kong
DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma	NCT02487017	Hepatocellular ... Neoplasms Digestive Syste...	Transcatheter A... DC-CIK	18 Years - 80 Years	Shenzhen Hornetcorn Bio-technology Company, LTD
Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)	NCT02921139	Hepatocellular ...	Stereotactic ab... Re-Transcathete...	20 Years -	Dalin Tzu Chi General Hospital
Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma	NCT05889949	Radiomics Hepatocellular ... Transcatheter A... Microvascular I... Multi-kinase In...	Sorafenib Lenvatinib	18 Years - 75 Years	Sun Yat-sen University
Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma	NCT05889949	Radiomics Hepatocellular ... Transcatheter A... Microvascular I... Multi-kinase In...	Sorafenib Lenvatinib	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for transcatheter arterial chemoembolization (tace)