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

Zhejiang University

Status and phase: Withdrawn; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Individualized Chemotherapy; Drug: mFOLFOX6

Study type: Interventional

Funder types: Other

Identifiers

NCT02580253

ZYYYMedOncoLT02

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Individualized Chemotherapy

Experimental group

Description:

Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)

Treatment:

Drug: Individualized Chemotherapy

mFOLFOX6

Active Comparator group

Description:

Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w

Treatment:

Drug: mFOLFOX6