Neo-TACE-HAIC for PVTT-HCC (NeoconceptC)

Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus: a Randomized Clinical Trial

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE).

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Portal Vein Thrombosis
• Intervention / Treatment: Procedure: neo-TACE-HAIC+Surgery; Procedure: Surgery alone

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-75 years;
• 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:

• Patients with primary hepatocellular carcinoma and major portal vein tumor thrombus
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: neo-TACE-HAIC with surgery; neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT	Procedure: 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
ACTIVE_COMPARATOR: surgery alone; surgery alone for HCC patients with PVTT	Procedure: Surgery alone; hepatic resection remove the liver tumor and portal vein tumor thrombus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2019
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (ACTUAL): December 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Embolism and Thrombosis; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Thrombosis
• Other Study ID Numbers: B2019-170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No