NCT03192618

Brief Summary

To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

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
290

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

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

June 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

5.5 years

First QC Date

June 16, 2017

Last Update Submit

June 19, 2017

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    disease-free survival

    From date of randomization until the date of recurrence, assessed up to 60 months

Secondary Outcomes (2)

  • recurrence rate

    1 year, 2 year, 3 year, 5 year after surgery

  • Overall survival (OS)

    From date of randomization until the date of death from any cause, assessed up to 60 months

Study Arms (2)

treatment group

EXPERIMENTAL
Procedure: adjuvant transarterial chemoinfusion (TAI)Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

control group

NO INTERVENTION

Interventions

adjuvant transarterial chemoinfusion (TAI)PROCEDURE

transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

treatment group
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)DRUG

oxaliplatin, calcium folinate, and 5-FU

treatment group

Eligibility Criteria

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

You may qualify if:

  • older than 18 years old and younger than 75 years;
  • ECOG PS\<3;
  • proven hepatocellular carcinoma with MVI according pathological examination;
  • not previous treated for tumor;
  • tumor was removed in operation;
  • no recurrence occurence at 4 to 7 weeks after surgery;
  • the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
  • sign up consent;
  • unrolled by other clinical trials about hepatocellular carcinoma.

You may not qualify if:

  • cannot tolerate TAI;
  • CNS or bone metastasis exits;
  • known history of other malignancy;
  • be allergic to related drugs;
  • underwent organ transplantation before;
  • be treated before (interferon included);
  • known history of HIV infection;
  • known history of drug or alcohol abuse;
  • have GI hemorreage or cardiac/brain vascular events within 30 days;
  • pregnancy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center of Sun Yat-Sen University

Guangzhou, +86, China

RECRUITING

Related Publications (2)

  • Li SH, Mei J, Cheng Y, Li Q, Wang QX, Fang CK, Lei QC, Huang HK, Cao MR, Luo R, Deng JD, Jiang YC, Zhao RC, Lu LH, Zou JW, Deng M, Lin WP, Guan RG, Wen YH, Li JB, Zheng L, Guo ZX, Ling YH, Chen HW, Zhong C, Wei W, Guo RP. Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study. J Clin Oncol. 2023 Apr 1;41(10):1898-1908. doi: 10.1200/JCO.22.01142. Epub 2022 Dec 16.

    PMID: 36525610DERIVED

  • Li S, Mei J, Wang Q, Guo Z, Lu L, Ling Y, Xu L, Chen M, Zheng L, Lin W, Zou J, Wen Y, Wei W, Guo R. Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial. Ann Surg Oncol. 2020 Dec;27(13):5183-5190. doi: 10.1245/s10434-020-08601-8. Epub 2020 May 16.

    PMID: 32418078DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

OxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Shaohua Li, MD

CONTACT

+8615088064187lishaoh@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

July 1, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

CN(1)