Spots Global Cancer Trial Database for Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

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Trial Identification

Brief Title: Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

Official Title: Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization

Study ID: NCT03722498

Conditions

Hepatocellular Carcinoma

Interventions

HAIC of FOLFOX

Sorafenib

Study Description

Brief Summary: To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

Detailed Description: In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months. Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE