Hepatocellular Carcinoma Clinical Trial
Official title:
A Randomized Controled Trial of Oral S-1 in Combination With Sequential Hepatic Arterial Infusion of Oxaliplatin After Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma has become the second carcinoma killer in China. Surgical resection or liver transplantation is the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a small portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard treatment of unresectable advanced hepatic carcinoma and has notable advantages in controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE can significantly increase the local doses of chemotherapeutic agents in the liver, kill micrometastases and residual foci after embolization and demonstrate outstanding efficacy for treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic agent with convenient use and definite efficacy and, when used concomitantly with TACE, theoretically can not only effectively control intrahepatic foci but also prevent and control extrahepatic metastatic foci. However, this hasn't been verified in clinical application. This study is intended to investigate efficacy and safety of the combination treatment so as to provide a more effective and safety way for treating patients with advanced hepatic carcinoma (Barcelona stage-C patients with concomitant portal vein tumor thrombi or extrahepatic metastasis).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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