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Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab

Hepatic arterial infusion chemotherapy plus lenvatinib

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Hepatic arterial infusion chemotherapy

12 mg (or 8 mg) once daily (QD) oral dosing

Toripalimab

oxaliplatin , fluorouracil, and leucovorin

Ming Shi, MD

Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.

FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial

Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib and Toripalimab Versus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Phase 3, Randomized Controlled and Double-blind Trial

OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.

Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Sun Yat-sen University

Professor

Rare Diseases

Cholangiocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Gemcitabine

Cisplatin

Participants received hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin

Participants received systemic chemotherapy of gemcitabine and cisplatin

administration of gemcitabine and cisplatin via vein

gemcitabine and cisplatin

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.

HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC

Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma

TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST).

Postoperative adverse events were graded based on CTCAE v4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial	NCT06201065	Hepatocellular ...	Hepatic arteria... Lenvatinib Toripalimab oxaliplatin , f...	18 Years - 75 Years	Sun Yat-sen University
HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC	NCT04961970	Intrahepatic Ch...	oxaliplatin , f... gemcitabine and...	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for oxaliplatin , fluorouracil, and leucovorin