Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
NCT ID: NCT03469479
Last Updated: 2018-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
252 participants
INTERVENTIONAL
2018-03-02
2023-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Resection plus HAIC with FOLFOX
Patients receive 4 times of neoadjuvant hepatic arterial infusion chemotherapy with FOLFOX and hepatic resection
FOLFOX
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Hepatic resection
R0 resection
Resection
Patients receive hepatic resection without neoadjuvant hepatic arterial infusion chemotherapy
Hepatic resection
R0 resection
Interventions
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FOLFOX
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Hepatic resection
R0 resection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Ming Shi
Proffessor
Principal Investigators
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Ming Shi, MD
Role: PRINCIPAL_INVESTIGATOR
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer
Locations
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Dongguan People's Hospital
Dongguan, Guangdong, China
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, China
Kaiping Central Hospital
Kaiping, Guangdong, China
The First Affiliated Hospital of University Of South China
Hengyang, Hunan, China
First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCC-180302
Identifier Type: -
Identifier Source: org_study_id
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