Clinical trial · Interventional
Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
NCT01125020CI-TRIAL-00003461unknownN/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)
The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemotherapy | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplantation | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
| Tumor Recurrence and Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin, 5-Fu and cisplatin | Drug | — | UNRESOLVED |
| gemcitabine and oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- gemcitabine and oxaliplatin
- interventionNames
- Drug: gemcitabine and oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- doxorubicin, 5-Fu and cisplatin
- interventionNames
- Drug: doxorubicin, 5-Fu and cisplatin
Primary outcomes (1)
- measure
- tumor recurrence and metastasis
- timeFrame
- within the first year after liver transplantation
- description
- Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment. Exclusion Criteria: * Age less than 18 years * Treatment with other postoperative adjuvant chemotherapy * Survival is less than 3 months after liver transplantation * Inability to provide written informed consent prior to study entry
References
Publications (3)
- BACKGROUNDDudek K, Kornasiewicz O, Remiszewski P, Kobryn K, Ziarkiewicz-Wroblewska B, Gornicka B, Zieniewicz K, Krawczyk M. Impact of tumor characteristic on the outcome of liver transplantation in patients with hepatocellular carcinoma. Transplant Proc. 2009 Oct;41(8):3135-7. doi: 10.1016/j.transproceed.2009.08.016. PMID 19857695
- BACKGROUNDSoderdahl G, Backman L, Isoniemi H, Cahlin C, Hockerstedt K, Broome U, Makisalo H, Friman S, Ericzon BG. A prospective, randomized, multi-centre trial of systemic adjuvant chemotherapy versus no additional treatment in liver transplantation for hepatocellular carcinoma. Transpl Int. 2006 Apr;19(4):288-94. doi: 10.1111/j.1432-2277.2006.00279.x. PMID 16573544
- BACKGROUNDLouafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532. PMID 17330837