Clinical trial · Interventional
Study of Folfox4 Chemotherapy Regimen to Prevent Early Postoperative Recurrence for HCC-PVTT Patients
Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection
NCT02813096CI-TRIAL-00024428unknownN/AClinicalTrials.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)
This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| folfox4 chemotherapy regimen | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- folfox4 chemotherapy regimen
- description
- details in the "Intervention Description"
- interventionNames
- Drug: folfox4 chemotherapy regimen
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- details in the "Intervention Description"
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- early recurrence
- timeFrame
- from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * patients undergo curative resection * HCC with PVTT is confirmed by pathological examination * patients undergo chemotherapy of Folfox4 regimen * patients without recurrence within the first month after curative resection * residual hepatic function is Child-pugh A or B which is capable to tolerate chemotherapy * patients without other postoperative adjuvant treatments including TACE, radiotherapy, immunotherapy Exclusion Criteria: * Multipal intra-hepatic or outra-hepatic tastasis within the first month after curative resection * patients with residual hepatic function Child-pugh C is not capable to tolerate chemotherapy * patients undergo postoperative adjuvant treatments except chemotherapy of Folfox4 regimen * patients with badly chemotherapy complications who can finish the whole Folfox4 treatment course
References
Publications (0)
Data not yet available
No reference posted for this study.