Liver Cancer Clinical Trial
Official title:
Proof-of-Concept Phase II Study to Evaluate the Anti-Tumor Activity of Sorafenib Along With Pathological and Molecular Changes in Tumor Samples From Patients With Resectable Hepatocellular Carcinoma
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating
patients with liver cancer that can be removed by surgery.
OBJECTIVES:
Primary
- To assess anti-tumor activity of neoadjuvant sorafenib tosylate in tumor samples from
patients with resectable hepatocellular carcinoma (HCC).
Secondary
- To characterize pathologic findings in sorafenib tosylate pre-treated patients
undergoing surgical resection for HCC: 1-2 core tumor biopsies will be performed prior
to treatment and at day 35.
- To evaluate the number of R0 resections in these patients.
- To correlate pathological biomarker changes in resected tumors after 4-week treatment
with sorafenib tosylate in comparison with biopsies obtained prior to treatment in
these patients.
- To evaluate plasma biomarkers, including PIGF, VEGF-A, VEGF-C, sVEGFR2, sVEGFR3, sKIT,
IL-6, Ang2, IL-8, bFGF, AFP, collagen 4, endostatin, thrombospondin, TSP-1 and
angiostatin, and CXCL12 at baseline, day 28, and the day before surgery.
- To identify potential biomarkers of sensitivity and/or resistance on biological and
pathological samples of these patients (exploratory).
- To characterize the safety profile of sorafenib tosylate in these patients.
- To assess the tolerance of liver resection after sorafenib tosylate treatment of these
patients.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 in the absence of
unacceptable toxicity. Approximately 7 days after completion of sorafenib tosylate therapy,
patients undergo liver resection.
Blood and tissue specimens are collected periodically for laboratory and biomarker
assessments. Biomarkers include both molecular markers investigating the direct antitumor
effects of sorafenib tosylate against cancer cells vs the effects of the drug on
angiogenesis.
After completion of study treatment, patients are followed up on day 50 and at 3 months
after surgery.
;
Masking: Open Label, Primary Purpose: Treatment
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