Clinical trial · Interventional
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
NCT03192644CI-TRIAL-00028197unknownPhase 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 recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epidoxorubicin and cisplatin and lipiodol | Drug | — | UNRESOLVED |
| mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
| TAI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (TAI)
- interventionNames
- Procedure: TAI
- Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
- type
- ACTIVE_COMPARATOR
- label
- Group B (TACE)
- interventionNames
- Procedure: TACE
- Drug: epidoxorubicin and cisplatin and lipiodol
Primary outcomes (1)
- measure
- recurrence-free survival (RFS)
- timeFrame
- From date of randomization until the date of recurrence, assessed up to 60 months
- description
- recurrence-free survival
Secondary outcomes (2)
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\<3; * proven hepatocellular carcinoma with PVTT according pathological examination; * not previous treated for tumor; * tumor and tumor thrombosis were 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. Exclusion Criteria: * cannot tolerate TACE or 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 hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy;
References
Publications (0)
Data not yet available
No reference posted for this study.