Neoplasms

All Conditions

Heart and Blood Diseases

Digestive System Diseases

Carcinoma

Thrombosis

Venous Thrombosis

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.

Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.

Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy.

Investigate a possible relationship between survival and degree of underlying liver dysfunction in patients with thrombosis or portal vein invasion in patients undergoing curative hepatectomy.

Hospital Sirio-Libanes

Attending physician

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Micronutrients

Anti-Infective Agents

Bevacizumab

Atezolizumab

Chlorotrianisene

Liver Extracts

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

Oxaliplatin

Doxorubicin

Liposomal doxorubicin

chemoembolization combined with endovascular stents and iodine-125 seed strand implantation

Transartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

Conventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

chemoembolization

endovascular stents implantation

Iodine-125 seed strand implant within portal vein.

iodine-125 seed strand implantation

Zhinping Yan, MD

Jianjun Luo, MD

The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.

Combination Treatment for Advanced Liver Cancer

Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery	NCT01690715	Hepatocellular ... Portal Vein Thr... Hepatic Portal ...		-	Hospital Sirio-Libanes
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
Combination Treatment for Advanced Liver Cancer	NCT02149771	Hepatocellular ... Hepatic Portal ...	chemoembolizati... endovascular st... iodine-125 seed...	20 Years - 70 Years	Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for hepatic portal vein tumor invasion