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Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines.

Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines plus the addition of biomarker assays (AFP, AFP-L3 and DCP) every 6 months.

Feld Jordan, MD

The objective of this study is to evaluate the clinical effectiveness of biomarkers, alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and des-gamma-carboxy prothrombin (DCP), for surveillance program patients whose hepatocellular carcinoma (HCC) development may be potentially missed by ultrasound (US). This study expects to demonstrate that addition of biomarkers will increase the detection rate by at least 10%.

This study is a prospective randomized controlled trial (RCT) comparing surveillance for hepatocellular carcinoma with ultrasound alone versus ultrasound and standard biomarkers. The study will be conducted initially at UHN (TGH and TWH). One arm will undergo surveillance for hepatocellular carcinoma using ultrasound (US) alone and the other will undergo HCC surveillance with US plus biomarkers (BM). The biomarkers to be used will be AFP, AFP-L3 and DCP). Subjects will undergo surveillance at 6 monthly intervals for a minimum of 2 years and up to 4 years. The endpoints will be the comparative effectiveness, defined as sensitivity and specificity of detection of HCC. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, biomarkers alone, and combined use of US and biomarkers. The target population is individuals who have liver cirrhosis and no HCC detectable at enrollment into the study. The factors contributing to the cause of the cirrhosis will be recorded but will not play a role into subject eligibility for the study

A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers

A Randomized Controlled Trial to Determine the Role of Biomarkers in Surveillance for Hepatocellular Carcinoma (HCC)

Biomarker assay levels that exceed threshold will trigger diagnostic imaging for HCC. Ultrasound imaging indicating a suspicious nodule may also trigger diagnostic imaging.

When the total number of HCC cases as diagnosed by CT/MRI have been observed. Approximately 300 cases in total half (150) the cases from each group

Wako Life Sciences

Infections

Cholangiocarcinoma

Hepatitis A

Hepatitis

Bile Duct Cancer

Vaccines

Immunomodulating Agents

Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC

hepcortespenlisimut-L (V5) is given in experimental arm

hepcortespenlisimut-L

Placebo

Aldar Bourinbaiar, MD/PhD

Galyna kutsyna, MD

aldar Bourinbaiar, MD

Aldar Bourinbaiar, MD

Chinburen Jigjidsuren, MD

Marina Tarakanovskaya, MD

aldar bourinbaiar

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.

Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L

Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)

Changes in plasma AFP levels at monthly intervals

changes in tumor size/mumber at 3 months compared to baseline

Immunitor LLC

Investigator

Recurrence

Disease Attributes

Consecutive patients who underwent liver transplantation for HCC at Italian transplant centers

Liver transplantation

Vincenzo Mazzaferro, MD PhD

Liver transplantation (LT) is one of the curative treatment options for patients with HCC associated to chronic liver disease (cirrhosis). All current international guidelines recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to select patients affected by HCC for LT was originally proposed with the Milan criteria. These criteria were based on pathologic assessment of number and size of the HCC nodules on the explanted liver. Subsequently, many authors proposed the expansion of such restrictive criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different combinations of morphologic parameters, have been defined on the pathologic staging of the tumor made on the removed liver, namely after LT, once decision on treatment and treatment itself could not be changed Although post-LT pathology / pre-LT radiology correlation have improved over time, significant biases still affect clinical assessment of HCC stage and no reliable protocols has entered clinical practice yet. In addition, robust evidence indicates that other biological markers of aggressiveness (such as α-Fetoprotein levels and clinical response to bridge therapies) have to be added when evaluating pre-operative variable Although many studies have been conducted, prognostic calculators of cancer-specific survival for HCC patients undergoing an evaluation for LT are not yet available. Such models should be able to provide survival estimates based on pre-treatment oncologic variables.

The main goal of the study is the definition of a cancer-specific prognostic model based on pre-operative features (radiologic staging and α-Fetoprotein levels) of a wide population of patients who underwent LT for HCC.

Considering the competitive risk of cancer-specific mortality and death due to other causes, the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the base of pathologic staging

Rationale: Liver transplantation (LT) is one of the curative treatment options for patients with HCC associated to chronic liver disease (cirrhosis). All current international guidelines recommend LT for HCC only within pre-defined criteria.

The use of restrictive criteria to select patients affected by HCC for LT was originally proposed with the Milan criteria. These criteria were based on pathologic assessment of number and size of the HCC nodules on the explanted liver. Subsequently, many authors proposed the expansion of such restrictive criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different combinations of morphologic parameters, have been defined on the pathologic staging of the tumor made on the removed liver, namely after LT, once decision on treatment and treatment itself could not be changed.

Over time, various attempts have also been made to correlate postoperative pathologic findings of HCC to preoperative clinical staging in order to anticipate decision-making. Should a reliable conversion algorithm correlating pre-operative staging with post-transplant prognosis be available a selection of LT candidates based on routine radiologic HCC findings would optimise survival patient survival and organ resource allocation.

Although post-LT pathology / pre-LT radiology correlation have improved over time, significant biases still affect clinical assessment of HCC stage and no reliable protocols has entered clinical practice yet. In addition, robust evidence indicates that other biological markers of aggressiveness (such as α-Fetoprotein levels and clinical response to bridge therapies) have to be added when evaluating pre-operative variables.

Another important issue to be considered when dealing with LT for HCC is the striking progress in treating chronic viral infections (HCV and HBV) that has been achieved over the last few years. Due to the possibility of treating recurrence of viral infections in the transplanted liver, these conditions do not significantly affect mortality following LT as they did in the past.

In the current scenario, the decreasing role of non-oncologic factors in survival of patients treated by LT for HCC enhances the need to define new prognostic models oriented towards cancer-specific survival. These models should include, besides conventional morphological parameters, also the response to bridge therapies delivered in the pre-transplant setting as well as other biologic markers commonly used in clinical practise such as α-Fetoprotein levels.

Although many studies have been conducted, prognostic calculators of cancer-specific survival for HCC patients undergoing an evaluation for LT are not yet available. Such models should be able to provide survival estimates based on pre-treatment oncologic variables.

A tailored assessment of cancer-specific prognosis is strongly advocated also by regulatory authorities, to optimize the allocation/distribution criteria of the limited source of available organs. Therefore, these criteria could be useful in the daily practise of transplant Centres to define different priority levels within the waiting list for LT, both for patients with and without HCC.

Endpoints and clinical relevance: The main goal of the study is the definition of a cancer-specific prognostic model based on pre-operative features (radiologic staging and α-Fetoprotein levels) of a wide population of patients who underwent LT for HCC.

Considering the competitive risk of cancer-specific mortality and death due to other causes, the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the base of pathologic staging.

Primary endpoints: besides conventional outcome endpoints, the study aims to develop and validate a prognostic calculator of recurrence rate and cancer-specific survival for HCC patients undergoing evaluation for LT.

The prognostic algorithm will be based on the competitive risk analysis of cancer-related recurrence and survival vs. non-cancer related outcome.

Clinical relevance: the development of an on-line available prognostic calculator based on pre-operative oncologic factors would provide precise estimates of survival. This could help in the comparison of patients with different disease stage and comorbidities, by defining progressive priority levels to be applied to the waiting list for LT.

The final goal is to provide reliable survival estimates for patients at different disease stage and therefore with different priority.

This perspective may have great clinical impact as would allow the definition of different priority levels for LT in HCC, both to provide a prognosis-oriented treatment for each patient and to optimise the global outcome of the population of patients eligible for LT.

Observational period: Retrospective analysis of a population of patients who underwent LT for HCC from January 2000 to December 2015.

Study population size: The expected number of patients from Italian centres is more than 1000 cases.

If the training set will allow the development of a cancer-specific prognostic model, at least 300 other cases will have to be added as a further set of external validation, preferably belonging to an Eastern series (see above).

Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC)

Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC) With Pre-transplant Radiology Assessment and Alpha-fetoprotein (α-fp)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

MD PhD

Fibrosis

Micronutrients

Coagulants

Vitamins

Thrombin

Vitamin K

Agglutinins

Trace Elements

Antifibrinolytic Agents

Hemostatics

Immunologic Factors

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

All participants will be examined with three biomarker tests and sonography every six months and contrast-enhanced CT annually.

AFP-L3 will be tested using serum sample every 6 months.

AFP-L3

AFP will be tested using serum sample every 6 months.

PIVKA-II will be tested using serum sample every 6 months.

PIVKA-II

Sonography will be tested by experts every 6 months.

Sonography

Contrast-enhanced CT will be tested annually.

Hyung Joon Yim, MD,PhD

Soon Ho Um, MD,PhD

Hyung Joon Yim

Tae Hyung Kim

Changwook Kim

Byoungkuk Jang

Eileen L. Yoon

Soon Ho Um

Yunjoon Kim

Doyoung Kim

Jae Young Jang

DaeWon Jun

Wonhyeok Choe

Youngseok Yim

Yonghan Paik

Jeong Won Jang

Hyungjoon Kim

Ji Hoon Kim

In this study, three biomarkers tests (AFP, AFP-L3 and PIVKA-II) and abdominal sonography or CT scans are performed every 6 months to detect hepatocellular carcinoma (HCC) early in patients with cirrhosis, a high-risk group of HCC. The aim of this study is to confirm the early HCC diagnosis rate in patients with cirrhosis and compare the detection efficacy between tests.

Early diagnosis of HCC is the most important factor in improving the prognosis of the disease. A surveillance test for early diagnosis of HCC in Korea is to perform alfa fetoprotein (AFP) and abdominal sonography every 6-months in high-risk groups. However, the detection rate of HCC using AFP and abdominal sonography is very low. There are several reports that the combination of the multiple biomarker tests including AFP, AFP L3, and PIVKA-II increased the early HCC detection only one test. Therefore, in the surveillance test for HCC, the combination of three tests with sonography would be helpful in the early diagnosis of HCC. However, there was few prospective large-scale studies about this issue.

Compared with abdominal sonography, contrast-enhanced CT or MRI is more useful in finding intrahepatic lesions of liver cirrhosis. However, there is no evidence data on combining sono/CT and biomarkers could improve the diagnosis for early HCC. Thus, it is essential to verify this prospectively in the real clinical practices to make recommendations based on a high level of evidence in the future. The investigators are conducting a prospective study which examines three biomarker tests and sonography every six months and contrast-enhanced CT annually for HCC surveillance in patients with cirrhosis.

Patients with cirrhosis will receive the surveillance test using three biomarker tests and sonography every six months and contrast-enhanced CT annually

Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma

Clinical Usefulness of Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) With Abdominal Sonography or Computed Tomography for Early Detection of Hepatocellular Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...		18 Years -	Wako Life Sciences
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...		18 Years -	Wako Life Sciences
Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L	NCT02232490	Hepatocellular ... HCC Liver Cancer	hepcortespenlis... Placebo	18 Years -	Immunitor LLC
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...		18 Years -	Wako Life Sciences
Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC)	NCT02898415	HCC Liver Transplan... Alphafetoprotei... Mortality Competing Risk Selection Crite... Cancer Recurren...	Liver transplan...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma	NCT04414956	Liver Cirrhosis Hepatocellular ... Surveillance	AFP-L3 AFP PIVKA-II Sonography CT	19 Years - 75 Years	Korea University

Spots Global Cancer Trial Database for afp

Every month we try and update this database with for afp cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for afp

Every month we try and update this database with for afp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for afp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.