Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    252
  • sponsor
    Sun Yat-sen University
Updated on 1 March 2022
platelet count
fluorouracil
cirrhosis
oxaliplatin
neutrophil count
folfox
TACE
radiofrequency ablation
hepatic arterial infusion

Summary

The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable hepatocellular carcinoma beyond Milan criteria.

Description

Resection is the long-term therapeutic option for resectable hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect and high relapse rate of resection for patients with resectable hepatocellular carcinoma beyond Milan criteria. Our previous prospective study also revealed that neoadjuvant transarterial chemoembolization (TACE) seems to confer a survival benefit for resectable HCC. Recently, the results of our previous prospective study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC.Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of resection plus neoadjuvant HAIC over resection alone.

Details
Condition Hepatocellular Carcinoma
Treatment Hepatic resection, FOLFOX
Clinical Study IdentifierNCT03469479
SponsorSun Yat-sen University
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL
Tumor burden beyond Milan criteria
Diagnosed as resectable with consensus by the panel of liver surgery experts
No past history of resection, radiofrequency ablation, TACE, TAI, chemotherapy or molecule-targeted treatment
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Meet the following laboratory parameters:(a) Platelet count 75,000/L; (b)Hemoglobin 8.5 g/dL;(c) Total bilirubin 30mmol/L;(d) Serum albumin
g/L;(e) ASL and AST 6 x upper limit of normal;(f) Serum creatinine
5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h)
Absolute neutrophil count (ANC) >1,500/mm3
Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
Known history of HIV
History of organ allograft
Known or suspected allergy to the investigational agents or any agent given in association with this trial
Evidence of bleeding diathesis
Any other hemorrhage/bleeding event > CTCAE Grade 3
Serious non-healing wound, ulcer, or bone fracture
Known central nervous system tumors including metastatic brain disease
Poor compliance that can not comply with the course of treatment and follow up
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