CTDx

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CDx for Drug Repositioning

BACKGROUND

A major challenge of chemotherapeutic agents is the selection of the eligible patients. Specifically, 1 st generation of anti-cancer drugs acts on cells without tumor selectivity and have limitation for the personalized treatment of cancer patients' This emphasizes the urgent need to develop predictive biomarkers. The development and clinical implementation of biomarkers that predict response t。 cytotoxic drug could facilitate selecting the most efficacious therapeutic regimen given the molecular characteristics of an individual 's tumor. Furthermore, predictive biomarkers could repurpose commonly used chemotherapeutic drugs in new indication and produce the highest value with low risk

CLlNICAL TRIAL

Hepatic arterial infusion chemotherapy (HAIC) with Cisplatin and 5-Fluorouracil has been used in advanced HCC. HAIC with cisplatin and 5-FU is superior in its efficacy to that of Sorafenib. Previously, we identified that HMGB2 suppressed Cisplatin-induced cell death in HCC cell lines. Based on the result, we designed a phase 2b prospective clinical trial to assess the efficacy and the safety of HAIC of Cisplatin and 5-luorouracil in advanced HCC patients stratified by HMGB2 gene expression as a biomarker predicting therapeu tic response to Cisplatin. Currently, IND of the protocol was approved by Korea FDA and the clinical trial is in progress in 11 medical centers.

REFERENCES

  • J Gastroenterol. 2015 50(4): 445-54
  • Cancer Chemother Pharmacol 201065: 373-382
  • Cancer Chemother Pharmacol 2015 75(4): 739-46
  • Br. J . Cancer 2013 109: 1904-1907
  • Clin. Cancer Res. 2010 16(22): 5511-5522

PROTOCOL

Patients

Advanced HCC patients who have progressed or intolerance to Sorafenib non-metastatic HCC in TNM stage III-IVA ECOG PS 0 or 1 Child-Pugh class A or B

Treatment

96 patients with pre-treatment tumor biopsy wi ll receive Cisplatin (60mg/m2 for 2h on day 2) and 5-Fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system . This treatment wi ll be repeated every 4 weeks ,up to 6 times

Treatment & Follow-up Full Process

1 cycle treatment process