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

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Adenosine; Fluorouracil; Oxaliplatin

Criteria

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.