Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

Summary

Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.

Timeline

Start

2013-11

Primary completion

2018-11

Completion

2019-02

Drugs

Indications