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
NA
320 participants
INTERVENTIONAL
2019-12-16
2024-12-30
Brief Summary
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Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC.
Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.
Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
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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neo-TACE-HAIC with surgery
neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT
neo-TACE-HAIC+Surgery
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
surgery alone
surgery alone for HCC patients with PVTT
Surgery alone
hepatic resection remove the liver tumor and portal vein tumor thrombus
Interventions
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neo-TACE-HAIC+Surgery
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
Surgery alone
hepatic resection remove the liver tumor and portal vein tumor thrombus
Eligibility Criteria
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Inclusion Criteria
* Patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein;
* Child-Pugh A or B (7 score) liver function;
* With more than 3 months expected survival;
* The volume of residual liver more than 30%
Exclusion Criteria
* With extrahepatic metastasis or unresectable HCC
* Pregnant woman or sucking period;
* With other malignant cancer;
* Received chemotherapy, target therapy or immunosuppressive drugs therapy before this study.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yunfei Yuan
Professor
Principal Investigators
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Yunfei Yuan, MD.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2019-170
Identifier Type: -
Identifier Source: org_study_id