The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial...
Hepatocellular CarcinomaTo compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.
TACE vs TACE+SBRT for Unresectable Hepatocellular Cancer
CarcinomaHepatocellularVast majority of patients with hepatocellular carcinoma (HCC) present with unresectable disease. In the last decade results of randomized trials and a subsequent metaanalyses established transarterial chemoembolization (TACE) or systemic chemotherapy (sorafenib) as standard of care. However, TACE alone is not a curative approach. The two year survival following TACE ranges from 31-63% with almost 100% patients developing disease progression after treatment. There is need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent metaanalyses concluded that addition of high dose radiation to TACE results in 10-35% improvement in two year overall survival. However as results of metaanalyses were based on studies with small sample size, unclear randomization procedure and heterogenous dose of radiation, the need for conducting a high quality randomized study was highlighted The present study is designed to investigate the role of high dose conformal radiation as consolidation therapy after TACE in patients with nonmetastatic unresectable HCC.
HR Versus RFA for HCC in Patients With PHT
CarcinomaHepatocellular3 moreThe purpose of the investigators' study is to prospectively compare the safety and efficacy of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients with portal hypertension.
Pembrolizumab in Hepatocellular Carcinoma
HCCThis is a single-arm Phase II trial of pembrolizumab in patients with hepatitis B virus-related hepatocellular carcinoma with parallel study on baseline and serial change in the immune environment. Subjects should have a confirmed diagnosis of HCC (in accordance with the AASLD guideline) and confirmed chronic infection with hepatitis B virus as defined by positivity for HBsAg. Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. They must have disease not amenable to a curative treatment approach or loco-ablation. Subject must be fit and agreeable with baseline and post-treatment biopsy of tumor. Subjects must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 and adequate organ functions. 30 subjects will be enrolled to receive pembrolizumab 200 mg IV every 3 weeks(Q3W). Pre-treatment and on-treatment biopsy after 2 cycles of Pembrolizumab will be preformed. Treatment will be stopped when progression of disease or intolerable toxicity occurs. The primary objectives of this trial are to study the efficacy and safety of pembrolizumab in patients with HBV-related HCC and to study the serial change in RNA expression of immune-related gene panel in post-treatment biopsy tissue. The secondary objectives of this trial are to study the serial change in cytokine profile between pre-treatment and post-treatment samples, to study the PD-L1 immunohistochemical (IHC) expression in tumor sample at baseline and post-treatment tissue samples and to study the presence of tumor infiltrating lymphocytes in the baseline and post-treatment tumor samples. The exploratory objective of this trial is to evaluate the possibility of using baseline and the serial change in RNA expression of immune-related gene panel or PD-L1/2 IHC to predict treatment response.
Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced...
HepatocarcinomaLung Cancer8 moreThis trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.
Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline...
CarcinomaHepatocellularWe propose a randomized controlled study to compare the treatment efficacy of microwave ablation to liver resection for hepatocellular carcinoma (HCC) in patients with borderline liver function.
TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Hepatocellular CarcinomaThis is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.
Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular...
Advanced Hepatocellular CarcinomaCombination of anti-angiogenic molecular targeted therapy and anti- programmed cell death -1 immune checkpoint inhibitor (ICI) therapy has shown promising antitumor activity in multiple cancer types, including patients with advanced hepatocellular carcinoma (HCC). The safety profile and optimal dosage of targeted therapy should be carefully evaluated by clinical trials. Regorafenib is one of the standard second-line systemic therapy for advanced HCC. The present study will test the safety and efficacy of combination of regorafenib and tislelizumab, an anti-programmed cell death-1 ICI. The investigator(s) thus hypothesized that combination of tislelizumab and regorafenib is a tolerable regimen and may improve treatment efficacy for patients with advanced HCC. The present study will explore safety and efficacy of the combination of tislelizumab plus regorafenib as first-line therapy for advanced HCC.
RFA Using Gradual RF Energy Delivery Mode With Octopus Electrodes
Radiofrequency AblationCarcinoma1 moreThe investigators intend to perform RFA therapy on HCC less than 4 cm in size using octopus electrode, double alternating unipolar high-frequency transmission mode and gradual high-frequency energy loading mode, and to find out the therapeutic results. The primary evaluation variable is the ideal technical success rate for securing a safety margin of 5 mm or more around the tumor on the CT obtained immediately after the procedure, and the secondary evaluation variable is the volume of the cauterization lesion per unit time measured on the CT obtained immediately after the procedure, The local tumor recurrence rate, survival rate and disease-free survival rate of 12 months after the procedure, the presence or absence of multiple recurrences within the same segment, the actual procedure time, and the incidence of complications associated with the procedure are examined. The performance of RFA therapy of HCC using the Octopus electrode and gradual high-frequency energy transfer mode is compared with that of the existing Octopus electrode and RFA therapy using the basic maximum high-frequency energy transfer mode using historic cohort.
Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive...
Hepatocellular Carcinoma Stage IIIBCholangiocarcinoma3 moreThis trial is to evaluate the palliative effects of colchicine on primary hepatic malignancy using the Department of Health R.O.C. approved doses and methods of administration. Colchicine will be started from 2 tablets after meal twice per day (total 2 mg), adjust the dose ranging from total minimum 1.5 mg to maximum 3 mg per day based on the condition and tolerance of the participant. One cycle of treatment is defined as 4 days treatment and 3 days off. The participants will receive repeated treatment cycles till the participants quit the trial. The control group will be originated from review of (1) patients treated by members of this research team with the same condition as the trial selected participants but not included in the trial, (2) patients with same condition as the trial selected participants reported in the literatures. The primary objective is to evaluate the palliative effects of colchicine on primary hepatic malignancy unable to receive curative treatment. The primary end point is survival of the participant. The Secondary objective is to evaluate the safety of patients treated by colchicine and the secondary end point is the side effects of colchicine.