Clinical trial · Interventional
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
NCT03192618CI-TRIAL-00028186unknownPhase 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 Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant transarterial chemoinfusion (TAI) | Procedure | — | UNRESOLVED |
| mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment group
- interventionNames
- Procedure: adjuvant transarterial chemoinfusion (TAI)
- Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
- type
- NO_INTERVENTION
- label
- control group
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- From date of randomization until the date of recurrence, assessed up to 60 months
- description
- disease-free survival
Secondary outcomes (2)
- measure
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 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. Exclusion Criteria: * 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;
References
Publications (2)
- DERIVEDLi 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 36525610
- DERIVEDLi 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 32418078