The purpose of this phase II study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular carcinoma (HCC).
The results of our preliminary pilot study suggested that the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to determine the recommended dose as well as the safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGTumor response
Tumor response evaluated by postoperative CT/MRI scan according to RECIST criteria.
Time frame: 3 Months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 days
Number of of Patients developed Adverse Events
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.