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

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).

TACE (Transcatheter arterial chemoembolization)

Joung-Soon Jang, M.D.

In Gyu Hwang, M.D.

Hyung Joon Kim, M.D.

Hyun Woong Lee, M.D.

To evaluate the time to progression of the combination therapy of Transcatheter Arterial Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or metastatic hepatocellular carcinoma.

Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)

Phase II Trial of TACE With Sorafenib in Patients With Locally Advanced Hepatocellular Carcinoma

Assessments including image and laboratory studies will take place within 7days of the every TACE cycle

Gyeongsang National University Hospital

Chung-Ang University

Joung-Soon Jang/Professor

Hematinics

Immunomodulating Agents

Liver Extracts

IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)

TACE (Transcatheter Arterial Chemoembolization)

IKC (Immune Killer Cells)

Executive Assistant

Chung-Bao Hsieh, MD

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：

1. Reduction of tumor size
2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.

60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.

Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes

The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse

Evaluate the efficacy and safety of in vitro proliferating autoimmune killer cells as adjuvant therapy for the treatment of liver cancer patients and promote anti-cancer immune responses

Tri-Service General Hospital

Ivy Life Sciences, Co., Ltd

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Ethiodized Oil

Anti-Bacterial Agents

Antibiotics, Antitubercular

After identifying the target artery of HCC, doxorubicin will be infused through the target artery of HCC patient with lipiodol emulsion (dependent on the tumor size)

doxorubicin

Yee Chao

TACE possibly plays a significant role in contributing to a subgroup of surviving residual tumor tissue which is characterized by more aggressive biology. This explains the strong scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the time to recurrence and progression. Performing TACE under sorafenib administration may have synergic effect on hepatic tumoral lesions.

Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial

Taipei Veterans General Hospital, Taiwan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)	NCT01170104	Hepatocellular ...	Sorafenib TACE (Transcath...	18 Years -	Chung-Ang University
Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)	NCT01170104	Hepatocellular ...	Sorafenib TACE (Transcath...	18 Years -	Chung-Ang University
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy	NCT03592706	HepatoCellular ... Liver Cancer	IKC (Immune Kil... TACE (Transcath...	20 Years - 79 Years	Ivy Life Sciences, Co., Ltd
Study in Asia of the Combination of TACE With Sorafenib in HCC Patients	NCT00990860	Hepatocellular ...	doxorubicin TACE (Transcath...	18 Years -	Taipei Veterans General Hospital, Taiwan
Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)	NCT01170104	Hepatocellular ...	Sorafenib TACE (Transcath...	18 Years -	Chung-Ang University
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy	NCT03592706	HepatoCellular ... Liver Cancer	IKC (Immune Kil... TACE (Transcath...	20 Years - 79 Years	Ivy Life Sciences, Co., Ltd

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