NCT01088581

CompletedPhase 3

Adjuvant Hepatic Arterial Infusional Chemotherapy After Cura...

Yonsei University Source

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

4-2005-0203

Study Type

interventional

Actual enrollment (reported)

101

Locations

1 country

Sites

1

Timeline

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2007

Actual (reported)

Study Completion

December 2008

Actual (reported)

Brief Summary

Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC). However, because the efficacy of such adjuvant therapy remains unclear, there is no standard postoperative therapy. The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with 5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative resection.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 101 participants
Study completion date: December 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)
Study Completion
December 2008
Actual (reported)
First Submitted
March 16, 2010
Actual (reported)
First Posted
March 17, 2010
Actual (reported)

Last Updated: February 2, 2012
Status Verified: January 2012
Last Update Submitted: January 31, 2012

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomahepatic arterial infusion chemotherapy5-fluorouracilcisplatinadjuvant chemotherapyhepatectomy

Outcome Measures

Primary Outcomes (1)

2-year recurrence rate and adverse events
2-year

Secondary Outcomes (1)

overall survival
2-year

Study Arms (2)

Observation group

NO INTERVENTION

No adjuvant chemotherapy after resection

Adjuvant group

ACTIVE COMPARATOR

Adjuvant chemotherapy after resection

Drug: Adjuvant group

Interventions

Adjuvant groupDrug

Adjuvant chemotherapy (5FU and cisplatin) after resection

Also known as: Adjuvant chemotherapy after resection

Adjuvant group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

age of 18 to 70 years old
appropriate blood test results (white blood cells (WBCs) ≥3,000/mm3, platelet count ≥50,000/mm3, total bilirubin \<3mg/dl)

Sponsors & Collaborators

Yonsei University
Otherlead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

Seung Up Kim, MD
Yonsei University
STUDY DIRECTOR

Enrollment

101 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Completed

NCT00355862

Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma

Phase 3Completed

NCT00460681

Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma

Phase 3Unknown

NCT00471965

Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients

Phase 3Completed

NCT00492752

A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Phase 3Completed

NCT05489289

A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

Phase 3Recruiting

NCT00501813

Multimodality Therapy for Palliative Resectable Hepatocellular Carcinoma With Intrahepatic Vessels Invasion

Phase 3Unknown

a patient could enter this study if one of the following was fulfilled

maximum diameter of HCC ≥5 cm,

microvascular or bile duct invasion upon pathological examination,

capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner grade III or IV.

You may not qualify if:

patients with intra- or extrahepatic metastases at 4 weeks after resection
Child-Pugh class B or C (n = 4)
ECOG performance scale ≥2
prior systemic chemotherapy, radiation, or locoregional therapy

Contact the study team to confirm eligibility.

Primary Completion

December 2007

Actual (reported)

Study Completion

December 2008

Actual (reported)

Last Updated

February 2, 2012

Record last verified: 2012-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01088581
Data provider: ClinicalTrials.gov
Source updated: 2012-02-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:19 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Observation group

Adjuvant group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations