Nanjing Drum tower hospital
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
NCT Number: NCT04595864
Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. Milan (solitary tumour <5cm, or up to 3 tumours, each <3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none >4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of >70% and recurrence rate ranging from 5-15% can be achieved.
Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria,and qualify for LT.
This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Neutrophil count≥2.0×109/L; Hemoglobin≥100g/L; Platelet count≥75×109/L; Serum albumin≥35g/L; Total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; Serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
Exclusion criteria
TAI
Other names: TAI
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
From date of randomization until the date of death from any cause, assessed up to 60 months
Time frame: From date of randomization until the date of recurrence, assessed up to 60 months
recurrence-free survival
Time frame: 1 year, 2 year, 3 year, 5 year after surgery
recurrence rate
Time frame: From date of randomization until the date of progression, assessed up to 60 months
progression free survival
Contact information is provided by the study sponsor or research team.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05475613
Adenocarcinoma, Carcinoma
Guangzhou, Guangdong, China
View Trial DetailsNCT05866783
Adenocarcinoma, Carcinoma
Ghent, Belgium
View Trial DetailsNCT07310836
Adenocarcinoma, Carcinoma
View Trial DetailsNCT06409507
Adenocarcinoma, Carcinoma
View Trial Details