NCT04181931

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

December 16, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

November 25, 2019

Last Update Submit

October 22, 2020

Conditions

Hepatocellular CarcinomaPortal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall survival, OS

    60 months

Study Arms (2)

neo-TACE-HAIC with surgery

EXPERIMENTAL

neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT

Procedure: neo-TACE-HAIC+Surgery

surgery alone

ACTIVE COMPARATOR

surgery alone for HCC patients with PVTT

Procedure: Surgery alone

Interventions

neo-TACE-HAIC+SurgeryPROCEDURE

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

neo-TACE-HAIC with surgery
Surgery alonePROCEDURE

hepatic resection remove the liver tumor and portal vein tumor thrombus

surgery alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yunfei Yuan, MD.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiliang Qiu, MD.

CONTACT

862087343114qiujl@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 2, 2019

Study Start

December 16, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2024

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)