Sorafenib Tosylate in Treating Patients With Liver Cancer That Can Be Removed by Surgery
Recruitment status was: Recruiting
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.
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Antiangiogenic effects of sorafenib tosylate [ Designated as safety issue: No ]
- Significant pathological changes [ Designated as safety issue: No ]
- Pathologic findings in sorafenib tosylate pre-treated patients undergoing surgical resection for hepatocellular carcinoma [ Designated as safety issue: No ]
- Number of R0 resections [ Designated as safety issue: No ]
- Correlations between baseline patient characteristics, cancer biomarkers, and outcome variables and resected tumors [ Designated as safety issue: No ]
- Plasma biomarkers at baseline, day 28, and the day before surgery [ Designated as safety issue: No ]
- Safety profile of sorafenib tosylate [ Designated as safety issue: Yes ]
- Tolerance of liver resection after sorafenib tosylate treatment [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
- To assess anti-tumor activity of neoadjuvant sorafenib tosylate in tumor samples from patients with resectable hepatocellular carcinoma (HCC).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182272
|Clichy, France, 92110|
|Principal Investigator:||Sandrine Faivre||Hopital Beaujon|