Neo-TACE-HAIC for BCLC B Stage HCC

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable 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 BCLC B stage 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.

Official Title
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Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Barcelona Clinic Liver Cancer (BCLC) B Stage: a Randomized Clinical Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: neo-TACE-HAIC+Surgery
* Procedure: Surgery alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age 18-75 years; BCLC B stage and tumor number <=4; Patients with resectable primary hepatocellular carcinoma; Child-Pugh A or B (7 score) liver function; The volume of residual liver more than 30% Exclusion Criteria: • With unresectable HCC Pregnant woman or sucking period; With other malignant cancer; Received anti-HCC therapy before this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neo-TACE-HAIC with surgery<br>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 | Procedure: neo-TACE-HAIC+Surgery<br>* 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<br>|
| Active Comparator: surgery alone<br>hepatic resection remove the liver tumors | Procedure: Surgery alone<br>* hepatic resection remove the liver tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, PFS | PFS was calculated from the date of starting treatment to the date of progression, of disease or death | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, OS | OS was calculated from the date of starting treatment to the date of death. | 60 months |