Clinical trial · Interventional
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy: A Random, Controlled, Stage III Clinical Trial
NCT03851913CI-TRIAL-00041996unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
- interventionNames
- Procedure: TAI
- type
- NO_INTERVENTION
- label
- control group
- description
- no neo-adjuvant treatment before operation
Primary outcomes (1)
- measure
- OS
- timeFrame
- From date of randomization until the date of death from any cause, assessed up to 60 months
- description
- overall survival
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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; * the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria; * 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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.