Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Individualized Chemotherapy
* Drug: mFOLFOX6


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Chemotherapy<br>Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin) | Drug: Individualized Chemotherapy<br>* Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)<br>|
| Active Comparator: mFOLFOX6<br>Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w | Drug: mFOLFOX6<br>* Oxaliplatin,Fluorouracil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desease free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years |