Spots Global Cancer Trial Database for Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

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Trial Identification

Brief Title: Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

Official Title: Second Line Therapy With Regorafenib and HAIC Compared to FOLFOX for Advanced Intrahepatic Cholangiocarcinoma

Study ID: NCT05535647

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

Regorafenib and HAIC

FOLFOX

Study Description

Brief Summary: This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.

Detailed Description: Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). However,only less than 25% of patients are resectable at diagnosis and, even in this subset of patients, relapse rate is high. Cisplatin and gemcitabine combination was identified as the standard first-line chemotherapy, yielding a median progression free survival (PFS) and median OS of 8.5 and 11.7 months, respectively. FOLFOX was the standard second-line chemotherapy. But the benefit of FOLFOX was limited.