Spots Global Cancer Trial Database for A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients

Study Description

Brief Summary: Hepatocellular carcinoma (HCC) is a prevalent malignancy with great disease burden both in Taiwan and worldwide 1. Early stage HCC can be treated by surgical resection, radiofrequency ablation, embolization and liver transplantation. However, treatments for advanced HCC are still unsatisfactory. Systemic therapy is necessary for advanced HCC 2. Target therapy using sorafenib was established a decade ago, but its response rate is quite low (\~3%), the adverse effects may be intolerable and it can only extend survival 2.3 to 2.8 months 3,4. Newly developed tyrosine kinase inhibitors (TKIs) include regorafenib 5, lenvatinib 6, cabozantinib 7 and ramucirumab 8. The single target therapy objective response rate is around 3-24%. Recently, immune checkpoint inhibitors (ICIs) emerged as a new hope for cancer therapy in various kinds of malignancies including HCC. These include CTLA4, PD-1 and PD-L1 blockades.

Detailed Description: This is an open-label, phase I pilot study. A total of 10 patients will be recruited in National Taiwan University Hospital between October, 01, 2021 and December, 31 2023. All examinations and treatment will be performed at National Taiwan University Hospital. The inclusion criteria are Child-Pugh classification A, unresectable HCC patients with age more than 20 years-old and radiologically measurable disease that is at least 2 cm in longest dimension of the target tumor.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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