Stereotactic Body Radiotherapy for Unresectable Hepatocellular Carcinoma
Localized Non-Resectable Adult Hepatocellular Carcinoma1. Background 1.1. Hepatocellular carcinoma (HCC) HCC is the third most common cause of cancer death globally. It is also the second cause of cancer mortality in Korea, despite the incidence of HCC was fifth. The most important cause of this discrepancy is connected with the fact that the significant portion of the HCC is detected as unresectable status. 1.2. Standard treatment of the HCC At the point of HCC diagnosis, only 30% of the patients could receive standard curative treatment, like resection, liver transplantation, and radiofrequency ablation (RFA). Transcatheter arterial chemoembolization (TACE) has been shown in randomized trials to improve survival compared with symptomatic therapy alone, in the patients without macrovascular involvement, extrahepatic disease and tumor related symptoms. However, in the recent review of TACE, TACE might be contraindicate or not recommended in the patients who showed vascular tumor invasion, more than 10 cm size, poor portal blood flow and/or repeated poor response. Recently, Sorafenib, which is one of the target agents, showed survival advantage on unresectable HCC patients in two randomized study. In those study, sorafenib improved approximately three month overall survival increment, however, the median survival duration was only 10.7 months in experiment group (received sorafenib), and even 6.5 months in Asian-Pacific trial. Additionally, the possibility that sorafenib effect could be reduced in the patients had hepatitis B virus (HBV) was suggested in the subgroup analysis. 1.3 Radiation therapy (RT) for the HCC The use of RT in HCC is increased with the radiation technological advances. In the unresectable patients, RT showed 50 to 60% response rate with the dose response relationship. Recently, stereotactic body radiation therapy (SBRT) showed excellent local control and comparable survival rate in thoracic tumor. In the HCC, SBRT also showed 75 to 100% local control rate without significant elevation of the toxicities. One study reported that 24 to 54 Gy SBRT achieved 87% 1year local control and 17 months overall survival. The standard treatment of unresectable HCC is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in localized unresectable HCC. Furthermore, Radiation Therapy Oncology Group (RTOG) started randomized trial to confirm the effect of SBRT in unresectable HCC (RTOG 1112). Investigators previously reported the retrospective result that the higher dose SBRT achieved 2 year overall survival 87.9% and local control 85% in the patient who showed less than 5 cm solitary HCC without portal vein involvement. Based on those studies, we start this prospective study to evaluate the effectiveness and adverse event of SBRT in the patients who had solitary 3 cm or less size HCC without extrahepatic lesion and vascular involvement.
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization...
Hepatocellular CarcinomaThe purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.
Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced...
Hepatocellular CarcinomaThe primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS). The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy.
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular...
Hepatocellular CarcinomaHepatitis B Virus1 moreMost hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis
Hepatocellular CarcinomaThe purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.
Cytotoxicity Induced by Tumor Lysate Pulsed Dendritic Cells Against Autologous Hepatocellular Carcinoma...
CarcinomaHepatocellularHepatoma ranks the first on the cancer mortality list in Taiwan, and there are currently no other effective treatment options for advanced HCC. Therefore, alternative medical intervention is needed to improve the survival and quality of life of these patients. Dendritic cells are the most potent type of antigen presenting cells in the human body, and are involved in the regulation of both innate and adoptive immune responses. If we use matured antigen presenting cells pulsed in vitro with appropriate tumor associated antigens under optimal activation conditions. It is anticipated that such treatment might generate or reactivate a cytotoxic T lymphocyte response against tumor cells and thereby inhibit tumor growth. Although there are excited results of tumor vaccine in animal models but successful clinical tries are rare. There are still some problems needed to be resolved such as immune deficiency of the cancer patients or the defect of T cell receptors or the problems of tumor escape. There are complex compositions in tumor cells to be a tumor antigen that will influence the efficacy of tumor vaccine, so we are going to use tumor lysate to be a tumor antigen. In this study, the generation of dendritic cells from the patient's peripheral blood will use rhGM-CSF and rhIL-4 as stimulating factors, and matured dendritic cells will pulse with tumor lysate, the ex vivo T cell cytotoxicity for the primary tumor cell will be test. We hope to cooperate with basic study group in our hospital to do more ex vivo tests and clinical trials in the future.
Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
Hepatocellular CarcinomaThe purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.
The Study of The Treatment of Postoperative Adjuvant Apatinib vs. TACE in Hepatocellular Carcinoma...
Hepatocellular CarcinomaThis study uses to suppress the growth of tumors, extend the patient's survival time and improve the quality of life as much as possible. Through the treatment, the patient is given the chance to undergo surgical resection, thereby more effectively prolonging the OS. Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR and exerting anti-angiogenic effects. Preclinical studies have shown that its antitumor effect is better than that of the similar drug PTK787. Phase II studies of hepatocellular carcinoma have initially demonstrated the effectiveness and safety of apatinib in the treatment of advanced HCC. TACE embolized tumor artery blood supply to inhibit tumor growth and shrink tumors. Based on the therapeutic potential of apatinib, and TACE in their respective tumors, we designed a prospective exploratory clinical study of this patient with advanced liver cancer.
Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma (HCC)Objectives: To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC; To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment; To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.
Effect of Babaodan on Tumor Recurrence After Curative Resection of Hepatocellular Carcinoma
Hepatocellular CarcinomaTumor RecurrenceThe aim of this study is to evaluate the effect of traditional Chinese medicine Babaodan on tumor recurrence of hepatocellular carcinoma after curative resection, as well as the safety of this treatment