Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
NCT Number: NCT05489692
Intrahepatic cholangiocarcinoma (ICC) is associated with poor prognosis. This study aims to explore the efficacy and safety FOLFOX-HAIC in combination with targeted therapy and/or PD-1 inhibitors for patients with initially unresectable ICC, as well as its role in conversion therapy. Data were retrospectively reviewed for patients with locally advanced unresectable ICC treated with FOLFOX-HAIC combined with targeted therapy and/or PD-1 inhibitors. The treatment efficacy and safety were evaluated.
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Notify Me18 year and older
All sexes
Observational
Guangzhou, Guangdong, 510060, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FOLFOX-HAIC as the following dosage: 130 mg/m2 oxaliplatin infusion for 2 hours; 400 mg/m2 of leucovorin infusion for 2 hours; and 400 mg/ m2 of 5-FU bolus and 1200 of mg/m2 continuous infusion of 5-FU for 23 hours.
Patients received targeted therapy, three different targeted therapy were applied including: 1. lenvatinib 2. sorafenib; 3. apatinib. A portion of patients received PD-1 inhibitor administered intravenously every three weeks.
Other names: targeted therapy, PD-1 inhibitors
Time frame: 12 months
The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1
Time frame: 24 months
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
Time frame: 24 months
Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up.
Time frame: 24 months
Rate of patients underwent hepatic surgery after careful evaluation when an estimated residual liver volume >30-40% could be remained after R0 surgery by 2 experienced surgeons.
Sun Yat-sen University
Other
Hepatic Arterial Infusion Chemotherapy Plus Targeted Therapy and/or PD-1 Inhibitors as Conversion Treatment for Unresectable Intrahepatic Cholangiocarcinoma
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