This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,115
HAIC is a regional therapy that takes advantage of the fact that hepatic tumors, particularly hepatocellular carcinoma, predominantly receive their blood supply from the hepatic artery. The procedure typically involves the insertion of a catheter into the hepatic artery, often through a percutaneous approach or during a surgical procedure. FOLFOX (5-fluorouracil, leucovorin combined with oxaliplatin) or RALOX (raltitrexed combined with oxaliplatin) Q3W.
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGRen Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGProgression-Free Survival (PFS)
Defined as the time from the date of enrollment to the date of any recorded tumor progression or death from any cause.
Time frame: 2 years
Time to Progression (TTP)
Defined as the time from the date of enrollment to the date of any recorded tumor progression.
Time frame: 2 years
adverse events
Incidence and grading of adverse events (AE) and serious adverse events (SAE).
Time frame: 2 years
Overall Survival (OS)
Defined as the time from the start of patient enrollment to death from any cause.
Time frame: 2 years
Objective Response Rate (ORR)
Defined as the percentage of subjects with the best response of CR or PR among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards).
Time frame: 2 years
Disease Control Rate (DCR)
Defined as the percentage of subjects with the best response of CR, PR, or SD among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards).
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.