Lead Investigator: Tao Han, The First Hospital of China Medical University
Title of Proposal Research: Clinical and molecular profiles of Hepatocellular Carcinoma (HCC)
Vivli Data Request: 9834
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Liver cancer ranks as the sixth most common cancer and the third leading cause of cancer-related deaths globally. Hepatocellular carcinoma (HCC), accounting for over 80% of liver cancer cases, is the primary cause of cancer deaths worldwide. As clinical trials for HCC progress rapidly, numerous studies are focused on novel therapeutic agents that have the potential to improve patient outcomes. However, there is still a lack of evaluation regarding the effectiveness of various treatment options.
The aim of this study is to assess the impact of various clinical and molecular factors on the efficacy of current treatment methods, thereby promoting the development of personalized treatment strategies for HCC. To achieve this, we plan to conduct an analysis using the data from clinical trials that have already been conducted to investigate the prognostic value (how well they can predict disease progress) of HCC’s clinical features (such as tumor size, whether it has spread to other places) and molecular markers (such as the presence of particular genes) and their correlation with clinical outcomes.
Participants in each trial will be categorized into different subgroups based on key clinical and molecular characteristics that may be associated with treatment response. A meta-analysis will be performed, this is where the results of several studies will be combined and analyzed together, to compare the effectiveness of each subgroup for each characteristic or endpoint.
The analysis will compare overall survival (OS) (the percentage of people who are alive five years after diagnosis or start of treatment) and disease-free survival (DFS) (the time between cancer treatment and signs that it has come back) between subgroups. It will also look at pathologic complete response (pCR) (the absence of any active cancer cells after treatment) in patients who received neoadjuvant therapy (treatment given before the main treatment to increase that treatment’s chances of success). These analyses will provide insights into patients’ responses to different treatment approaches.
By considering the impact of clinical and molecular factors, this study aims to personalize treatment approaches and ultimately improve patient outcomes. The findings of this study are expected to inform clinical decision-making, enabling more tailored and effective treatment strategies for patients with HCC.
Requested Studies:
A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib
Data Contributor: Bayer
Study ID: NCT01774344
Sponsor ID: 15982
A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients.
Data Contributor: Boehringer Ingelheim
Study ID: NCT01004003
Sponsor ID: 1199.37
A Multicenter, Open Label, Phase I/Randomized II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Sorafenib for Advanced Hepatocellular Carcinoma Patients in Asia.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00987935
Sponsor ID: 1199.39
Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)
Data Contributor: NIDDK Central
Study ID: NCT01263587
Sponsor ID: DK082864
A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Data Contributor: Roche
Study ID: NCT03434379
Sponsor ID: YO40245
A Randomised, Double-blind, Parallel Group, Multi-centre, Phase II Study to Assess the Efficacy and Safety of Best Support Care (BSC) Plus ZD6474(Vandetanib) 300 mg, BSC Plus ZD6474(Vandetanib) 100 mg, and BSC Plus Placebo in Patients With Inoperable Hepatocellular Carcinoma (HCC)
Data Contributor: Sanofi
Study ID: NCT00508001
Sponsor ID: D4200C00072