Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Hepatocellular

Pancreatic Neoplasms

Liver Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Pancreatic Cancer

Bile Duct Cancer

Gallbladder Cancer

MR Imaging

Amit Sawant

Paul J Keall

This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.

Accurate dose delivery remains one of the weakest aspects of radiotherapy, especially in the case of thoracic and abdominal tumors, where significant patient motion occurs during dose delivery (intrafraction motion). Such motion results in geometric and dosimetric uncertainties that compromise treatment quality. Effective management of intrafraction motion is therefore key to realizing the full potential of modern image-guided radiation therapy (IGRT). While external markers have been found to be well-correlated with internal anatomy within an imaging session, there is no guarantee that these correlations will continue to exist and be constant throughout the course of the therapy. In general, implanted, radio-opaque seeds have been found to be more reliable than external markers. However, implantation of fiducials, whether radio-opaque or electromagnetic, is necessarily invasive and carries with it the risk of associated complications - an issue that becomes especially important for cancer patients with weakened immune systems. Currently, MR imaging is the only modality that is non-invasive and provides high quality volumetric information for the whole body.

The "ideal" intrafraction motion management requires complete spatio-temporal knowledge of the irradiated anatomy. However, to date, there is no clinical method of directly visualizing the tumor volume during dose delivery. Most techniques rely on external or internal surrogate markers which often provide (usually non-volumetric) information of limited accuracy and reliability. In addition, internal markers impose significant "costs" on the patient in terms of interventional complications and increased imaging dose. In this work, we investigate the feasibility of using in-room, fast cine MR imaging as a non-invasive means to provide real-time, soft-tissue-based, volumetric image guidance for continuous monitoring of the target and surrounding anatomy. To date, there has been no systematic investigation of the imaging requirements of an integrated MRI+linac for the specific task of real-time radiotherapy guidance.

Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors

Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors

The American Association of Physicists in Medicine

Stanford University

Infections

Symptoms and General Pathology

Hepatitis A

Hepatitis C

Hepatitis

Hepatitis B

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Blood-Borne Infections

Flaviviridae Infections

Hepadnaviridae Infections

DNA Virus Infections

Herpes Simiae (B Virus)

Samuel So

Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.

Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma

Viral and Host Factors Associated With Development of Hepatitis B Virus-related Hepatocellular Carcinoma

We will be using blood specimens collected through another protocol

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Durvalumab

Liver Extracts

Tremelimumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

unresectable hepatocellular carcinoma (uHCC)

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

AstraZeneca Clinical Study Information Center

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence).

LIVER-R is a real-world, multi-country, multi-centre study aiming to enroll approximately 2500 pts with unresectable hepatocellular carcinoma (uHCC; n=1135) or advanced biliary tract cancers (aBTCs; n=1355) across 22 countries from North and South America, Europe, the Middle East and the Asia-Pacific region. The study design will include primary and secondary data collection. Primary data will be collected in real-time during the patient's routine visit. Secondary data will be collected from the patient's medical record at enrollment and at prespecified study time points (6-month intervals). The study population includes adult patients whose physician has previously made the decision to treat them with a durvalumab-based regimen for hepatobiliary cancer as part of routine clinical practice or patients receiving treatment through EAP. The study will include a baseline period of up to 5 years before the index date (initiation of a Durvalumab-based regimen) and a follow-up period to the earliest of death, loss to follow-up, withdrawal, or end of study for a maximum follow-up of 2 years for patients with aBTCs or 3 years for patients with uHCC. This is a descriptive, noncomparative study. No formal hypotheses are to be tested. All descriptive analyses will be conducted separately for each primary hepatobiliary cancer indication. Kaplan Meier estimates will be produced for time-to-event outcomes.

Observational Study Protocol: LIVER-R

An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers

Plan to share only the redacted CSR synopsis

rwOS will be calculated as the time from the index date to date of death, by any cause.

rwDOT will be calculated for each systemic treatment as the time from the index date to date of discontinuation for any reason.

rwPFS will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment or death, whichever is earlier.

rwTTP will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment.

rwTTNT will be calculated as the time from the index date to the date of initiation of the next treatment.

rwRFS will be defined as the time from the index date to the date of documented disease recurrence as determined by the physician's assessment or death, whichever is earlier. The analysis will be performed in patients who underwent curative therapy (resection or ablation).

rwTTR will be defined as the time from the index date to the date of documented disease recurrence as determined by the physician's assessment. The analysis will be performed in patients who underwent curative therapy (resection or ablation).

Descriptive statistics will be used to describe demographic and clinical characteristics for the enrolled patients.

Treatment patterns will be calculated from the index date until death, loss to follow-up, withdrawal from the study, or end of the study, whichever is earliest.

CSEs of interest leading to medical intervention including durvalumab based treatment interruption, discontinuation, hospitalization, or which require interventions of concomitant use of corticosteroids, immunosuppressants and/or endocrine therapies will be captured for the enrolled patients.

ICON plc

AstraZeneca

Liver cancer is a leading cause of cancer deaths worldwide. While the molecular pathogenesis of liver cancer has been extensively studied, less is known about how the molecular biology of liver cancer influences clinical outcome and treatment response. We are developing a translational research program that will characterize molecular changes in liver cancer. We plan to use molecular information obtained from studying liver tumor tissues to develop new diagnostics and treatment regimens for patients with these cancers. The experimental approach will require freezing fresh tumor tissues obtained from surgical procedures, which will be subsequently used for analysis of DNA, protein and mRNA expression. Many patients with liver cancer are referred to the Stanford Liver Tumor Board for consultation and treatment recommendations. We propose to gather tissue samples from those who subsequently undergo biopsy, liver resection surgery, or transplant surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors	NCT01071434	Pancreatic Canc... Liver Cancer Lung Cancer Lung Cancer Non... Lung Cancer Sma... Hepatobiliary C... Hepatobiliary C... Hepatobiliary C... Hepatobiliary C... Hepatobiliary C...	MR Imaging	18 Years -	Stanford University
Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma	NCT00767936	Liver Cancer Hepatitis B Hepatitis C Hepatobiliary C... Hepatobiliary C...		18 Years -	Stanford University
Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma	NCT00767936	Liver Cancer Hepatitis B Hepatitis C Hepatobiliary C... Hepatobiliary C...		18 Years -	Stanford University
Observational Study Protocol: LIVER-R	NCT06252753	Hepatobiliary C...	Durvalumab-base... Durvalumab-base...	18 Years - 130 Years	AstraZeneca
Genetic Analysis of Liver Cancer	NCT00768001	Liver Cancer Hepatitis B Hepatitis C Hepatobiliary C... Hepatobiliary C...		18 Years -	Stanford University

Spots Global Cancer Trial Database for hepatobiliary cancers