Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost

James Pingpank, MD

To evaluate the safety, toxicity and immunological effects of adjuvant administration of an experimental therapy consisting on priming with three intramuscular administrations of a plasmid expressing human AFP (phAFP) together with a plasmid expressing human GM-CSF (phGM-CSF), followed by a single intramuscular boost with an AFP adenoviral vector (AdVhAFP) to patients with locoregionally pre-treated hepatocellular carcinoma (HCC).

Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma

A Phase I/II Trial Testing Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma

National Cancer Institute (NCI)

Lisa H. Butterfield, Ph.D.

Professor of Medicine, Surgery and Immunology

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Nivolumab

Ipilimumab

Chlorotrianisene

Liver Extracts

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

nivolumab

ipilimumab

TACE

Bristol-Myers Squibb

The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories

Microwave ablation

Hyunchul Rhim, MD

This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.

This prospective, single-arm single center study will provide clinical data for the Neuwave Medical Microwave Ablation System and accessories.

Individuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled.

The enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis.

The subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.

Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced MRI and CT scans

complete tumor ablation with adequate or insufficient ablation margin based on contrast-enhanced MRI and CT scans; scans may be done up to 14 days prior to the 1 month visit

Ethicon, Inc.

Participants will be evaluated for AEs and SAEs at every study visit starting with the ablation procedure (Day 0) through the end-of-study (3 years following the ablation procedure). Adverse event data collection is still ongoing and will be updated upon study completion.

Each participant underwent microwave ablation of a liver tumor (Hepatocellular Carcinoma (HCC)) at a single visit. The treating physician determined the ablation time and power used on a case-by-case basis.

Microwave Ablation

Age of patient at the time of informed consent

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Maximum Tumor Dimension

Segment 3

Segment 4

Segment 5

Segment 6

Segment 7

Segment 8

Location of the tumor in the liver (multiple could be selected)

Liver Segment

Superficial

Deep

Dome

Tumor Depth

Near Major Vessel/Duct

No Major Vessel/Duct Near Ablation

Location of the tumor/ablation in relation to a major vessel/duct

Major Vessel/Duct Assessment

0 (Very early stage disease; Child-Pugh score of A, ECOG 0-1, single tumor < 2cm)

A (Early stage disease; Child-Pugh score of A/B, ECOG 0-1, single or 2-3 tumors < 3cm)

B (Intermediate stage disease; Child-Pugh score of A/B, ECOG 0-1, multinodular tumors)

C (Advanced stage disease; Child-Pugh score of A/B, ECOG 0-2, portal vein invasion)

D (Terminal disease; Child-Pugh score C, ECOG>2, metastasized tumors to lymph nodes or other organs)

All participants were confirmed to have BCLC staging of Stage A within 5 weeks prior to the day of ablation based on imaging and biopsy confirmation in accordance with their institution SOC. The BCLC (Barcelona Clinic Liver Cancer) staging system is validated and widely accepted as it offers the most prognostic information (i.e. includes information on tumor size/burden, liver function, and patient ECOG performance status). BCLC stages include 0, A, B, C and D.

BCLC Staging

Class A (mild liver disease; 5-6 points)

Class B (moderately severe liver disease; 7-9 points)

Class C (severe liver disease; 10-15 points)

All participants were confirmed to have functional hepatic reserve based on the Child-Pugh score (Class A or Class B) within 5 weeks prior to the day of ablation. Child-Pugh Scores assess the prognosis of liver disease. Five clinical features are assessed and assigned 1-3 points depending on severity (1 being none, 2 being mild, and 3 being severe): encephalopathy, presence of ascites, bilirubin blood level, albumin blood level, and prothrombin time prolongation. Classes A, B, and C are based on the total number of points.

Child-Pugh Score

33 total patients were enrolled, to allow for 30 patients to be treated per protocol.

Jaclyn Calia

PI Assessment

Independent Reviewer Assessment

Number of Patients Whose Ablation Resulted in Technical Success

Participants analyzed at 1 month post-ablation

Number of Patients Whose Ablation Resulted in Technique Efficacy

Overall Study

Multiparametric MRI scans will be used to evaluate baseline degree of liver fibroinflammation and function as well as temporal changes in liver fibroinflammation and function using MRI-based LiverMultiScan software.

Eligible patients can have previously undergone any modality and number of prior treatments for their hepatic malignancies, must be considered for either liver photon or proton radiation in the de-novo or re-irradiation setting and can be simultaneously enrolled on parallel trials.

Multiparametric MRI scans will be used to evaluate baseline degree of liver fibroinflammation and function as well as temporal changes in liver fibroinflammation and function using MRI-based LiverMultiScan software. We will also measure liver function using HepQuant SHUNT test in a subset of patients enrolled in this study.

Multiparametric MRI scans

Eligible patients can have previously undergone any modality and number of prior treatments for their hepatic malignancies, must be considered for either liver photon or proton radiation in the de-novo or re-irradiation setting and can be simultaneously enrolled on parallel trials. Patients must not have any contraindications that would preclude MRI imaging or receipt of HepQuant SHUNT test for those agreeable to have HepQuant SHUNT test.

Multiparametric MRI scans + HepQuantShunt Test

Rafi Kabarriti, MD

Rikin Gandhi, MS

Rafi Kabbarriti, MD

The purpose of this study is to evaluate the role of quantitative MR imaging and blood-based biomarkers to measure liver function in patients receiving radiation therapy for liver cancer or cancer that has spread to the liver.

The purpose of this study is to evaluate the role of quantitative MR imaging and blood-based biomarkers to measure liver function in patients receiving radiation therapy for liver cancer or cancer that has spread to the liver. The feasibility of using MR imaging to monitor liver function at baseline and following liver radiation therapy will be determined. Information from MR images and blood samples, along with patient questionnaires, will be used.

A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer

Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging

Feasibility will be determined by assessing the percentage of patients who complete at least two quantitative multiparametric MRI scans after study enrollment. The feasibility endpoint will be presented as proportions and a Clopper Pearson 95% exact confidence interval will be determined.

Change in DSI scores from baseline will be evaluated using HepQuant SHUNT testing. The HepQuant SHUNT test measures hepatocyte function using the Disease Severity Index (DSI). Increased DSI scores have been correlated with worsening liver function and disease severity and progression and response to treatments. The DSI calculation is proprietary; however, the test generates a liver DSI score ranging from 0 (no hepatic impairment) to 50 (severe hepatic impairment) that is a composite of both hepatic filtration rates and correlates with stage of fibrosis, presence of varices, and risk for future clinical outcomes. Raw changes in DSI scoring from baseline scores will be summarized using descriptive statistics and will be examined using a paired t-test or Wilcoxon Sign rank test.

The ability of LiverMultiScan to predict the risk of non-classic RILD will be evaluated. The pre-radiotherapy liver health assessment score will be calculated by measuring the Future Liver Remnant volume outside the 50% radiation isodose line weighted by the liver cT1 value. MRI images will be post-processed using LiverMultiScan, which provides a multiparametric quantitative map of a region of interest in the liver including characterization of the underlying liver fibroinflammation as reported by a corrected T1 (cT1) value, which will be measured and reported in milliseconds (ms). The likelihood of non-classic RILD based on the cT1 value will be assessed using multivariable logistic regression.

Non-classic RILD is defined as either worsening of Child-Pugh Score by \>=2 points (overall range: 5-15 points) at 6 months following RT or an elevated aminotransferase (ALT or AST) level \> 5 times the upper limit of normal or baseline value within 90 days of completion of RT.

Change in total liver volume, as well as volume of non-irradiated and irradiated liver lobes, from pre-radiotherapy treatment at baseline will be evaluated using Gd-EOB-DTPA enhanced MRI of the abdomen at the specified timeframes to assess the impact of radiotherapy. Mean changes in total liver volume (cm\^3) and volume of non-irradiated and irradiate lobes will be assessed using the MRI software image analysis and summarized by study arm. The data will be analyzed using linear mixed-effects models. Increases in liver volume are correlated to more favorable outcomes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma	NCT00669136	Hepatocellular ... Hepatoma Liver Cancer, A... Liver Cell Carc... Liver Cell Carc... Cancer of Liver Cancer of the L... Cancer, Hepatoc... Hepatic Cancer Hepatic Neoplas... Hepatocellular ... Liver Cancer Neoplasms, Hepa... Neoplasms, Live...	AFP + GM-CSF Pl...	18 Years - 80 Years	University of Pittsburgh
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer	NCT04340193	Cancer, Hepatoc...	nivolumab ipilimumab TACE	18 Years -	Bristol-Myers Squibb
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma	NCT00669136	Hepatocellular ... Hepatoma Liver Cancer, A... Liver Cell Carc... Liver Cell Carc... Cancer of Liver Cancer of the L... Cancer, Hepatoc... Hepatic Cancer Hepatic Neoplas... Hepatocellular ... Liver Cancer Neoplasms, Hepa... Neoplasms, Live...	AFP + GM-CSF Pl...	18 Years - 80 Years	University of Pittsburgh
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea	NCT03586050	Carcinoma, Hepa... Hepatocellular ... Hepatocellular ... Cancer, Hepatoc...	Microwave ablat...	19 Years -	Ethicon, Inc.
A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer	NCT06144827	Cancer, Hepatoc... Radiotherapy Si...	Multiparametric... Multiparametric...	18 Years -	Montefiore Medical Center

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