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

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Liver Extracts

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

surgical resection followed by adjuvant sorafenib

removal of portion of liver containing cancer

hepatic resection

sorafenib either as adjuvant therapy after resection or as only treatment

Wei-Hua Guan, MD

Shuqun Cheng, MD

Patients with HCC with portal vein involvement not involving the bifurcation (vP1-vP3) and no evidence of extra-hepatic spread will be enrolled. Patients will be required to have Child's A liver function and no significant portal hypertension. Patients will be randomly assigned with a 1:1 ratio to either surgery followed by adjuvant sorafenib or sorafenib alone. Patients will be followed by serial imaging. The primary end-point is overall survival.

Trial design

Surgery + sorafenib vs. sorafenib 100 patients per arm Centralized randomization by CRO Need to call CRO for treatment allocation Primary end-point - OS Secondary end-point Progression free survival (PFS) Randomized 1:1 Stratification Vp1-2 vs. Vp3 AFP ≤400 vs AFP \>400 Intention to treat Surgery aborted or R1-2 resection will remain in surgical arm No cross over CT scan chest/abdomen 4 weeks after surgery as post-operative baseline Will not alter treatment allocation Will allow for PFS measurement in surgical arm CT scan chest/abdomen pelvis Q 12 weeks after initiation sorafenib Patients progressing on sorafenib allowed 2nd line treatment Regorafenib or lenvatinib - if approved in China Dose reduction sorafenib as per protocol

A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion

time from initiation of intervention until progression as defined by RESIST

Eastern Hepatobiliary Surgery Hospital

Sun Yat-sen University

West China Hospital

Cancer Hospital of Guangxi Medical University

Anhui Provincial Hospital

Fujian Cancer Hospital

Wenzhou People's Hospital

White Plains Hospital

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Cisplatin

Chlorotrianisene

Anti-Bacterial Agents

Antibiotics, Antitubercular

Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination

Transarterial chemoembolization with doxorubicin

Transarterial chemoembolization (TACE) with adriamycin

transarterial chemoinfusion with cisplatin 50-100 mg

Jung-Hwan Yoon, M.D., Ph.D.

The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.

The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Seoul National University Hospital

Professor

Apatinib

Xiao-Dong Zhu

Xiao-Dong Zhu, MD&PhD

Hui-CHuan Sun, MD&PhD

Jia Fan, MD&PhD

In this phase 2 study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for hepatocellular carcinoma with portal vein tumor thrombus.

Portal vein tumor thrombus (PVTT) is one of the characteristics of advanced stage for patients with hepatocellular carcinoma (HCC). There's limited treatment choice for these patients. Even for those who underwent curative resection (R0 resection), the recurrence rate was extremely high. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor. Phase 2 study of apatinib for patients with advanced HCC had shown signals of clinical efficacy and modest safety. In this study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for HCC with PVTT.

Adjuvant Therapy With Apatinib for HCC Patients With PVTT Who Underwent Radical Resection

A Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection

From the date of liver surgery to the date of diagnosis of tumor recurrence

From the date of liver surgery to the date of death

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
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion	NCT03971201	Hepatocellular ...	hepatic resecti... Sorafenib	18 Years -	White Plains Hospital
Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion	NCT01857726	Hepatocellular ...	Doxorubicin Cisplatin	18 Years - 80 Years	Seoul National University Hospital
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion	NCT03971201	Hepatocellular ...	hepatic resecti... Sorafenib	18 Years -	White Plains Hospital
Adjuvant Therapy With Apatinib for HCC Patients With PVTT Who Underwent Radical Resection	NCT03261791	Carcinoma, Hepa...	Apatinib	18 Years - 70 Years	Shanghai Zhongshan Hospital
A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion	NCT03971201	Hepatocellular ...	hepatic resecti... Sorafenib	18 Years -	White Plains Hospital

Spots Global Cancer Trial Database for portal vein invasion