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Neo-TACE-HAIC for BCLC B Stage HCC

NCT ID: NCT04424043

Last Updated: 2020-10-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2025-12-30

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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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neo-TACE-HAIC with 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

Group Type EXPERIMENTAL

neo-TACE-HAIC+Surgery

Intervention Type PROCEDURE

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 tumors

Group Type ACTIVE_COMPARATOR

Surgery alone

Intervention Type PROCEDURE

hepatic resection remove the liver tumors

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

Intervention Type PROCEDURE

Surgery alone

hepatic resection remove the liver tumors

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yunfei Yuan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiliang Qiu, MD.

Role: CONTACT

[email protected]
862087343114

Facility Contacts

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Jiliang Qiu, MD.

Role: primary

[email protected]
862087343114

Other Identifiers

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B2020-127

Identifier Type: -

Identifier Source: org_study_id