Lead Investigator: Jiabin Cai, Zhongshan Hospital
Title of Proposal Research: Clinical and Molecular Characterization of Advanced Hepatocellular Carcinoma: Analysis of Therapeutic Responses Across Multiple Treatment Regimens
Vivli Data Request: 10475
Funding Source: Our project received internal funding through a competitive grant process from Fudan University Medical Research Fund.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Hepatocellular carcinoma (HCC) is a type of liver cancer that affects thousands of people around the world each year. HCC is especially concerning because it is frequently detected when it has already spread, and treatment options are more limited.
To help improve outcomes for people with this cancer, doctors need better ways to understand how the disease behaves and which treatments will work best for each individual patient. That’s where biomarkers come in. Biomarkers are measurable indicators in the body that can give doctors clues about the disease, such as how far it has progressed or how well a treatment is working. Some biomarkers are related to genes or proteins, while others are linked to the immune system. By identifying these markers, we can develop more personalized treatment strategies, allowing doctors to tailor treatments to each patient’s needs.
This study will focus on a range of potential biomarkers to understand which treatments work best for people with advanced HCC. The treatments we’ll look at include Sorafenib, Regorafenib, Doxorubicin, and SHR-1210. Sorafenib and Regorafenib are medications that target specific proteins cancer cells need to grow, while Doxorubicin is a chemotherapy drug that kills cancer cells. SHR-1210 is a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells.
Our research will use data from multiple clinical trials to explore how these treatments affect patient outcomes, including survival rates and how well the cancer responds to the treatment. We will also examine a range of biomarkers, including genetic mutations, protein levels, and immune markers, which could indicate how well the immune system is fighting the cancer. Additionally, we will consider clinical factors such as tumor size, cancer stage, and liver function.
By analyzing all this information together, we aim to improve personalized treatment strategies and predict which patients are most likely to benefit from specific therapies.
Our ultimate goal is to enhance treatment efficacy and inform clinical decision-making for better management of 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 Randomized Controlled Multicentered Phase 2/3 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Failed or Intolerable to Prior Systemic Treatment
Data Contributor: ImmPort (a data-sharing platform funded by the National Institutes of Health)
Study ID: NCT02989922
Sponsor ID: SDY1733
Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
Data Contributor: Project Data Sphere
Study ID: NCT01015833
Sponsor ID: NCI-2011-01989
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