Clinical trial · Interventional
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
NCT02580253CI-TRIAL-00043449withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patients enrolled
Summary
Brief summary (as posted)
This study is a randomized, open-label, controlled study that will explore the efficacy of individualized adjuvant chemotherapy based on the adenosine triphosphate tumor chemosensitivity assay for patients with hepatocellular carcinoma after liver transplantation.
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 |
|---|---|---|---|
| Individualized Chemotherapy | Drug | — | UNRESOLVED |
| mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Individualized Chemotherapy
- description
- Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
- interventionNames
- Drug: Individualized Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- mFOLFOX6
- description
- Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w
- interventionNames
- Drug: mFOLFOX6
Primary outcomes (1)
- measure
- Desease free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who had experienced liver transplantation with histologically confirmed advanced hepatocellular carcinoma with more one risk factor (tumour burden \>8 cm, AFP\>400 ng/mL,poorly differentiated,vessels invasion ) * No extrahepatic metastasis confirmed with computed tomography (CT) or magnetic resonance imaging (MRI) * Additional inclusion criteria were age 18 years or older * Karnofsky performance status (KPS) of at least 70% * Adequate renal function, defined as creatinine clearance greater than 30 mL/min) * Adequate hepatic function, defined as ALT and AST less than 5× upper limit of normal * Adequate bone marrow function, defined as platelets greater than 100×10E9/L and WBC greater than 3.5×10E9/L. Exclusion Criteria: * The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain * Hypersensitivity to study drugs * Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start) * National Cancer Institute CommonToxicity Criteria (NCI-CTC) grade 3 or 4 sensory or motor neuropathy * Prior or concurrent malignancy (other than pancreatic cancer) * Female, pregnancy or breastfeeding.
References
Publications (1)
- BACKGROUNDLin HS, Wan RH, Gao LH, Li JF, Shan RF, Shi J. Adjuvant chemotherapy after liver transplantation for hepatocellular carcinoma: a systematic review and a meta-analysis. Hepatobiliary Pancreat Dis Int. 2015 Jun;14(3):236-45. doi: 10.1016/s1499-3872(15)60373-3. PMID 26063023