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

Phase 2

• Conditions: Liver Cancer

• Registration Number: NCT01182272
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief 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.

Study Timeline

• Study Start: 2010-05
• Status Verified: 2010-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-13
• Last Update Submitted: 2010-08-13
• Study First Posted: 2010-08-16
• Last Update Posted: 2010-08-16
• Primary Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antiangiogenic effects of sorafenib tosylate
Significant pathological changes

Secondary Outcome Measures

Name	Time	Method
Pathologic findings in sorafenib tosylate pre-treated patients undergoing surgical resection for hepatocellular carcinoma
Number of R0 resections
Correlations between baseline patient characteristics, cancer biomarkers, and outcome variables and resected tumors
Plasma biomarkers at baseline, day 28, and the day before surgery
Safety profile of sorafenib tosylate
Tolerance of liver resection after sorafenib tosylate treatment

Trial Locations

Locations (1)

Hopital Beaujon; 🇫🇷 Clichy, France