NCT01182272

Sorafenib Tosylate in Treating Patients With Liver Cancer That Can Be Removed by Surgery

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate
OTHER	laboratory biomarker analysis
PROCEDURE	neoadjuvant therapy
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-06-01
• First posted: 2010-08-16
• Last updated: 2010-08-16

Locations

1 site across 1 country: France