MTDx

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CDx for Molecular Targeted Drug

BACKGROUND

The effectiveness of molecular targeted drugs is modest in hepatocellular carcinoma (HCC). Efficacy of molecular targeted therapies has been better in cancer patients with high expression of cognate target molecules whereas low expression of resistance-related molecules. In this regard , we have developed the CDx tests based on the multi-gene expression analysis dictating the effectiveness of molecular targeted drugs in HCC

CLlNICAL TRIAL

For development of CDx, prospective and retrospective evaluation of clinical outcome of patients with gene expression data has been conducted.
CDx test for Sorafenib has been approved as class 111 in vitro diagnostics and currently evaluated in prospective and multi-center clinical trial . Retrospective and multi-center clinical evaluation of CDx test for HS mimetics has been completed .

REFERENCES

Jung-Hee Kwon / Namgyu Lee / Jin Young Park / Yun Suk Yu / Jin Pyo Kim / Ji Hye Shin / Dong-Sik Kim / Jae Won Joh / Dae Shick Kim / Kwan Yong Choi / Koo-Jeong Kang / Young Ho Moon / Hee Jung Wang (2013) Actionable gene expression-based patient
stratification for molecularly targeted therapy in hepatocellular carcinoma. PLOS ONE 8(6) : e64260

CDx CLlNICAL TRIAL FOR SORAFENIB

Patients diagnosed with advanced HCC (BCLC stage C) will be subjected to ultrasound-guided needle biopsy before sorafenib treatment.

Immediately after biopsy, separated HCC tissues will be snap-frozen in liquid nitrogen and subjected to gene expression analysis.

Tumor response to sorafenib is the endpoint of this study. Tumor response will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every 3 months after administration of sorafenib based upon the mRECIST criteria.

Patients with complete response (CR) or partial response (PR) will be considered as responders whereas those with stable disease (50) or progressive disease (PO) will be judged as non-responders.

Interim results (n = 36)

Study Sites

Seq. Medical Center
1 Ajou Medical Center
2 Catholic Medical Center Seoul
3 Gil Medical Center
4 Korea University Anam Medical Center
5 Samsung Medical Center
6 National Insurance IIsan Medical Center
7 Korea University Guro Medical Center
8 Asan Medical Center
9 Yonsei University Severance Hospital
10 Catholic Medical Center Incheon
11 Sooncheonhyang Medical Center Seoul

ENROLLMENT

Aimed number of patient enrollment is 400 and currently 91 patients have been enrolled

STATUS

Timeline of study completion: 3Q in 2018'