All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Amino Acids

Nilotinib

Liver Extracts

Dasatinib

Tyrosine Kinase Inhibitors

Lapatinib

Imatinib Mesylate

Erlotinib Hydrochloride

Gefitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Adults (age ≥18 years) with at least two ICD-9 codes for a particular cancer within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code

Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)

Tyrosine kinase inhibitors

GSK Clinical Trials

A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs).

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database

Prevalence of patients with an ALT elevation \>=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

Number of patients with ALT \>=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT \<1 times ULN at baseline.

Prevalence of patients with Hy's Law (ALT or AST \>=3x ULN and ALP \<2x ULN and BIL \>=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

Number of patients with Hy's Law (ALT or AST \>= 3x ULN and ALP \<2x ULN and BIL \>= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL \<1 times ULN at baseline.

Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up

Median time (in months) between index date and the date of maximum ALT elevation.

Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up

Median time (in months) between index date and date of maximum AST elevation

Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up

Median time (in months) between index date and date of maximum ALP elevation

Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up

Median time (in months) between index date and date of maximum BIL elevation

GlaxoSmithKline

This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.

Adult (age \>=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.

TKI Cohort

Age, Continuous

Female

Male

Unknown

Sex/Gender, Customized

GSK Response Center

Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.

Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)

Members of the TKI cohort who had normal ALT (\<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)

Incidence of ALT >=3x ULN

Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).

Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)

Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (\<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).

Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)

ALT: >=1x ULN to <3x ULN

ALT: >=3x ULN to <5x ULN

ALT: >=5x ULN to <10x ULN

ALT: >=10x ULN to <20x ULN

ALT: >=20x ULN

Members of the TKI cohort who had at least one incident ALT elevation during follow-up.

Maximum ALT Elevation Reached During Follow-up

ALT: >=10x ULN to <20x

Median Time to the Maximum ALT Elevation During Follow-up

AST: >=1x ULN to <3x ULN

AST: >=3x ULN to <5x ULN

AST: >=5x ULN to <10x ULN

AST: >=10x ULN to <20x ULN

AST: >=20x ULN

Members of the TKI cohort who had at least one incident AST elevation during follow-up.

Maximum AST Elevation Reached During Follow-up

Median Time to the Maximum AST Elevation During Follow-up

ALP: >=1x ULN to <2x ULN

ALP: >=2x ULN to <3x ULN

ALP: >=3x ULN to <5x ULN

ALP: >=5x ULN to <10x ULN

ALP: >=10x ULN

Members of the TKI cohort who had at least one incident ALP elevation during follow-up.

Maximum ALP Elevation Reached During Follow-up

Median Time to the Maximum ALP Elevation During Follow-up

BIL: >=1x ULN to <1.5x ULN

BIL: >=1.5x ULN to <2x ULN

BIL: >=2x ULN to <5x ULN

BIL: >=5x ULN to <10x ULN

BIL: >=10x ULN

Members of the TKI cohort who had at least one incident BIL elevation during follow-up.

Maximum BIL Elevation Reached During Follow-up

Median Time to the Maximum BIL Elevation During Follow-up

Overall Study

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

Chlorotrianisene

Patients undergo TACE of low-osmolar contrast media on day 1.

Patients undergo TACE of iso-osmolar contrast media on day 1.

Gao-Jun Teng, MD

Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the world. In men is the fifth most frequently diagnosed cancer worldwide but the second most frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and 695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were estimated to occur in China. Surgical resection and liver transplantation can be curative treatment options, but less than 20% of PHC patients are candidates for surgery. The prognosis of patients with unresectable PHC is poor; if left untreated, the median survival is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a palliative treatment in patients with unresectable HCC, it has become one of the most common forms of interventional therapy. However, the possibility of treatment-related complication may offset the survival benefit, especially by the worsening of liver functions.TACE increases several parameters of hepatic cytolysis and decreases the metabolic activity of the liver. Such a deterioration of liver function due to ischemia following TACE may result in liver failure, or even death. TACE also may have an adverse effect on the kidney. Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown that the use of contrast medium increases the risk of renal failure, especially the low-osmolar contrast media. The aim of this trials was to compare the change of liver and renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar contrast media.

This was a prospective, randomized, single centre, single-blind study. Patients were randomized (1:1) to use Low-osmolar contrast media or iso-osmolar contrast media for TACE.

On the morning of 2th and 5th days after TACE, a hematologic check was performed, the hematologic check including serum creatinine, blood urea nitrogen, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase. Then, comparing them with the data before TACE.

Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media

Comparison of Liver and Renal Function After TACE for PHC With Iso-osmolar and Low-osmolar Contrast Media

Li Chen

Zhongda Hospital, Southeast University Nanjing, Jiangsu, China

Symptoms and General Pathology

Postoperative Complications

Micronutrients

Bone Density Conservation Agents

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Vitamin D3

Calciferol

Oral supplementation of 1,728,000 IU vitamin D3 in 3 days

Oral supplementation of placebo in 3 days

Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days

Oral supplementation of placebo in 3 consecutive days.

Placebo

Yuan-Hao Ku, MD

High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated.

Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

Including level of C-reactive protein and white blood cell (WBC) count

Including in-hospital infectious complications, Dindo-Clavien classification, volume of ascites, duration of ascites, intra-abdominal abscess, postoperative haemorrhage, pleural effusion, wall abscess, and eventration.

Taoyuan General Hospital

Nutritional and Metabolic Diseases

Rare Diseases

Obesity

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Esophageal Cancer

Those with histology and LFT's and quantificaiton of obesity

Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy

Noel E Donlon

There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.

Oesophageal cancer rates are increasing as a result of obesity in Western society. Thr investigators are evaluating the influence of viscerala dn subcutaneous obesity on overall outcomes of the participants. In addition the investigators are evaluating if there is a correlation with Liver Function Tests and liver histopathology such as steatosis on survival in participants and post operative sequele.

Obesity and Liver Function in Oesophageal Cancer

Elucidating the Role of Obesity, Liver Function and Pathology With Overall Outcomes in Oesophageal Cancer

St. James's Hospital, Ireland

Principal Investigator

Neoplasm Metastasis

Neoplastic Processes

Multimodal liver function assessment

Magnus Nilsson, MD PhD

In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and the correlation between volume and function is not always accurate. Several techniques to assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced CT and ICG, repeatedly performed before and after right hepatectomy in patients with colorectal liver metastases treated with neoadjuvant chemotherapy.

Multimodal Assessment of Liver Volume and Function

Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases

HBS, MRI, CT and ICG performed the day before surgery

HBS, MRI, CT and ICG performed 7 days after surgery

HBS, MRI, CT and ICG performed 28 days after surgery

Karolinska University Hospital

MD PhD

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Patients with good liver function as defined by no more than Child-Pugh Class A.

Patients with compromised liver function as defined by patients with Child-Pugh Class B.

Radiation: Stereotactic Radiosurgery using the CyberKnife System. The CyberKnife system has been cleared by the U.S. Food and Drug Administration (FDA) to treat lesions, tumors and conditions, anywhere in the body when radiation treatment is indicated. To address movement of target lesion during the respiratory cycle, the Synchrony™ option will be used.

The Synchrony option precisely tracks tumors in or near the target organ as they move, enabling the highly focused beams of radiation to destroy the tumors with minimal injury to adjacent normal tissue. The Synchrony option records the breathing movements of a patient's chest and combines that information with sequential x-ray pictures of tiny markers inserted inside or in the proximity of the tumor to enable precise delivery of radiation during any point in the respiration cycle. The CyberKnife system with the Synchrony option enables reduced normal tissue exposure by using smaller treatment margins and increased accuracy.

Stereotactic Radiosurgery using the CyberKnife System.

Joel Tepper, MD

The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).

The CyberKnife system has been cleared by the U.S. Food and Drug Administration (FDA) to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. In order to treat tumors during the respiratory cycle (vs. increasing the margin of treatment around the tumor to compensate for movement or requiring the patient to breath hold during the delivery of each beam), the Synchrony™ option, a system option that enables dynamic radiosurgery during respiration, will be used. The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife in two groups of patients with hepatocellular carcinoma (HCC).Group 1: Patients with HCC and Childs A cirrhosis, and patients with colorectal liver metastases. Group 2: Patients with Childs B cirrhosis. Patients will be irradiated with radiation doses using the CyberKnife system in 3-5 radiation fractions using guidance from fiducials placed by interventional radiology. Treatments will be delivered with standard CyberKnife procedures to account for respiratory motion and set up variations. The fiducial location will be the prime determinant of the delivery site and respiratory motion and fiducial markers will be placed via percutaneous approach by interventional radiology.

Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases

A Dose-finding, Safety and Preliminary Efficacy Study of Stereotactic Radiosurgery for Hepato-cellular Carcinoma and Metastatic Disease to the Liver.

To determine a tolerable dose, cumulative acute toxicity was collected (defined as toxicity occurring within 90 days of treatment initiation). Adverse events were graded by the Common Terminology Criteria for Adverse Events version 3.0. Tolerability was based on hepatic toxicity. A grading (severity) scale is provided for each adverse event (AE) term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

1 year local control defined as percentage of patients with freedom from local progression at a median follow-up time of 12.7 months. Progressive disease is defined as increase by \>= 50% of product of the two perpendicular diameters of an irradiated lesion.

Complete response (CR) is defined as disappearance of the target lesion, partial response (PR) as regression of measureable disease, progressive disease (PD) as increase by \>= 50% in product of the two perpendicular diameters of an irradiated lesion, and stable disease (SD) as all others not meeting criteria for CR, PR, or PD.

Overall survival is defined as percentage of patients remaining alive from start of study treatment to 1 year.

UNC Lineberger Comprehensive Cancer Center

Patients with hepatocellular carcinoma (HCC) who are not appropriate for surgical resection or radiofrequency ablation (RFA) as a bridge to transplant. The original cohort was not analyzed between good vs compromised liver function because there were only 2 patients with Child-Pugh Class B and secondary outcomes measured are thought to be more influenced by disease rather than liver function (which may be more relevant for toxicity).

Single Arm Patients With HCC or Liver Metastases

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Measure Description: A scale from 0-5 to describe a patient's level of functioning in terms of selfcare ability and activity level.

0, Fully active

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5. Dead

Eastern Cooperative Oncology Group (ECOG) Performance Status

The Child-Pugh score consists of five clinical features and is used to assess the prognosis of chronic liver disease and cirrhosis. The score employs five clinical measures of liver disease. Each measure is scored 1-3, with 3 indicating most severe derangement.

Child- Pugh Class:

A 5-6 points B 7-9 points C \>9 points

Child Pugh Score

Primary Disease

Any local therapy

Liver resection

Trans-arterial chemoembolization (TACE)

Radiofrequency ablation (RFA)

> 1 prior local therapy

Resection + RFA

Resection + TACE

Resection x2 + RFA

TACE + RFA x3

Prior liver-directed therapies

The original cohort was not analyzed between good vs compromised liver function because there were only 2 patients with Child-Pugh Class B and secondary outcomes measured are thought to be more influenced by disease rather than liver function (which may be more relevant for toxicity).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs	NCT01098500	Cancer	Tyrosine kinase...	18 Years -	GlaxoSmithKline
Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media	NCT01563484	Primary Hepatoc...		18 Years - 75 Years	Southeast University, China
Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy	NCT05887505	Hepatocellular ... Liver Function Postoperative C...	Vitamin D Placebo	20 Years -	Taoyuan General Hospital
Obesity and Liver Function in Oesophageal Cancer	NCT04152044	Obesity Liver Function	Observation of ...	-	St. James's Hospital, Ireland
Obesity and Liver Function in Oesophageal Cancer	NCT04152044	Obesity Liver Function	Observation of ...	-	St. James's Hospital, Ireland
Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media	NCT01563484	Primary Hepatoc...		18 Years - 75 Years	Southeast University, China
Multimodal Assessment of Liver Volume and Function	NCT03140917	Colorectal Canc... Liver Metastase...	Multimodal live...	18 Years -	Karolinska University Hospital
Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases	NCT01528878	Liver Neoplasms Colonic Neoplas... Metastatic Canc...	Stereotactic Ra...	18 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for liver function