[PDF][PDF] Re: design and endpoints of clinical trials in hepatocellular carcinoma

S Hunsberger, SP Ivy, MA Smith - Proceedings Part I. J Clin Oncol, 2007 - Citeseer
The commentary on design and endpoints of clinical trials in hepatocellular carcinoma
(HCC) by Llovet et al.(1) gives a relevant contribution to the methodological improvement of …

Imaging of hepatic toxicity of systemic therapy in a tertiary cancer centre: chemotherapy, haematopoietic stem cell transplantation, molecular targeted therapies, and …

F Alessandrino, SH Tirumani, KM Krajewski… - Clinical radiology, 2017 - Elsevier
Highlights•Most common types of drug-induced liver injuries in oncology are presented.•
Hepatotoxicity of chemotherapy and molecular targeted therapies is reviewed.•Imaging …

Prognostic factors for survival in patients treated in phase I clinical trials

L Janisch, R Mick, RL Schilsky, NJ Vogelzang… - Cancer, 1994 - Wiley Online Library
Background. Patients with advanced or metastatic cancer treated in Phase I clinical trials are
considered to have a poor prognosis. Survival from first treatment in a Phase I trial was …

The impact of modern chemotherapy and chemotherapy-associated liver injuries (CALI) on liver function: value of 99mTc-labelled-mebrofenin SPECT-hepatobiliary …

S Truant, C Baillet, V Gnemmi, M Fulbert… - Annals of surgical …, 2021 - Springer
Background Chemotherapy is increasingly used before hepatic resection, with controversial
impact regarding liver function. This study aimed to assess the capacity of 99mTc-labelled …

A phase II study of ABT-869 in hepatocellular carcinoma (HCC): Interim analysis

H Toh, P Chen, BI Carr, JJ Knox, S Gill… - Journal of Clinical …, 2009 - ascopubs.org
4581 Background: ABT-869 is a novel orally active, potent and selective inhibitor of the
vascular endothelial growth factor and platelet derived growth factor families of receptor …

Radiological endpoints as surrogates for survival benefit in hepatocellular carcinoma trials: all that glitters is not gold

G Cabibbo, J Bruix - Journal of hepatology, 2023 - journal-of-hepatology.eu
In the context of sequential treatments, time-to-event outcomes such as PFS are proposed to
have great clinical utility owing to the fact that PFS better captures timing of transition to …

Are We Ready to Include Organ-Impaired Patients in Oncology Trials? A Clinical Pharmacology Perspective on Recent Recommendations.

JC Masters, PH Wiernik - Journal of Clinical Pharmacology, 2018 - search.ebscohost.com
The article offers information on the recommendations over inclusion of organ-impaired
patients in oncology trials. Topics discussed include challenges of identifying investigators …

Drug-induced liver injury

RJ Andrade, N Chalasani, ES Björnsson… - Nature Reviews …, 2019 - nature.com
Drug-induced liver injury (DILI) is an adverse reaction to drugs or other xenobiotics that
occurs either as a predictable event when an individual is exposed to toxic doses of some …

Who is a 'healthy subject'?—consensus results on pivotal eligibility criteria for clinical trials

K Breithaupt-Groegler, C Coch, M Coenen… - European journal of …, 2017 - Springer
Introduction/Methods A discussion forum was hosted by the German not-for-profit
Association for Applied Human Pharmacology (AGAH eV) to critically review key eligibility …

Monitoring liver safety in drug development: the GSK experience

CM Hunt, JI Papay, RI Edwards, D Theodore… - Regulatory Toxicology …, 2007 - Elsevier
To promptly identify and evaluate liver safety events, an evidence-based liver safety system
was created for global Phase I–III clinical trials. The goals of this system included improving …