JVDE: The REACH-2 Study
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib
IRAS ID
179483
Contact name
Tim Meyer
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2014-005068-13
Duration of Study in the UK
2 years, 4 months, 6 days
Research summary
Summary of Research
Hepatocellular Carcinoma (HCC) accounts for 90% of liver cancers globally. Vascular Endothelial Growth Factor (VEGF) is a protein produced by cells that stimualtes and encourages Angiogenesis and Vasculogenesis. VEGF levels are increased in patients with HCC and are shown to correlate with rapid disease progression and reduced patient survival.
Ramucirumab works to inhibit angiogenesis. Angiogenesis inhibitor treatments are currently being looked at to treat cancers. Angiogenesis is a process through which blood vessels form from pre-existing blood vessels. It is a fundamental step in the transition of tumours from a benign state to a malignant one. Ramucirumab also inhibits vasculogenesis which is another process that can potentially help tumours to grow.
Ramucirumab already has approval in the USA to be used on its own and with another medicine called Paclitaxel to treat patients with Gastric cancers as a 'second-line' treatment. Lilly are currently looking into its benefit on other cancers.
To be eligible to participate in this study patients must be 18 years old or over and have a diagnosis of Hepatocellular Carcinoma (HCC Liver Cancer).
Study assessments will include: Physical examinations, ECGs, Questionnaire completion, blood and urine tests and radiological scans.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0431
Date of REC Opinion
22 Sep 2015
REC opinion
Further Information Favourable Opinion