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RecruitingNCT03368651Updated Dec 11, 2017

The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

A Phase 3 interventional study of TAI in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-11.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2016, registered Dec 2017).
  • Started Jan 2016; still recruiting 10 years 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 230 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • older than 18 years old and younger than 75 years;
  • ECOG PS≤1;
  • proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
  • not previous treated for tumor;
  • estimated tumor and tumor thrombosis could be removed en bloc in operation;
  • no distant metastasis;
  • the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
  • sign up consent;

Exclusion criteria

Exclusion Criteria:

  • cannot tolerate TAI or surgery;
  • distant 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 hemorrhage or cardiac/brain vascular events within 30 days;
  • pregnancy;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • Experimental
    treatment group

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

    Procedure: TAI

  • No intervention
    control group

    no neo-adjuvant treatment before operation

Interventions

  • ProcedureTAI

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

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    overall survival

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

Secondary outcomes

  1. recurrence-free survival (RFS)

    recurrence-free survival

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

  2. recurrence rate

    recurrence rate

    Time frame: 1 year, 2 year, 3 year, 5 year after surgery

07

Study locations

1 of 1 sites recruiting
  • Cancer Center of Sun Yat-Sen University
    Guangzhou, Guangdong +86, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2016 (actual). Primary completion is estimated for Nov 2026, 130 months after the start.

Of 83 non-industry phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 109. This study's planned 130 months is above that.

Counting every sponsor, half of 130 studies reached it within 57 months; a quarter within 44 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2017
First posted
Dec 11, 2017
StartActual
Jan 1, 2016
Primary completionEst.
Nov 30, 2026
CompletionEst.
Dec 31, 2028
Last update
Dec 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03368651
Lead sponsor
Sun Yat-sen University
Responsible party
Rong-ping Guo (Professor, Sun Yat-sen University) — Principal investigator
First posted
Dec 11, 2017
Start date
Jan 1, 2016
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Dec 11, 2017

Study contacts

Shaohua Li, MD
Contact
lishaoh@sysucc.org.cn
+8615088064187

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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