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

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Individualized Chemotherapy; Drug: mFOLFOX6

• Registration Number: NCT02580253
• Lead Sponsor: Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-17
• Study First Submitted QC: 2015-10-17
• Study First Posted: 2015-10-20
• Status Verified: 2017-06
• Study Start: 2017-11-01
• Primary Completion: 2018-11
• Study Completion: 2018-12
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Chemotherapy	Individualized Chemotherapy	Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
mFOLFOX6	mFOLFOX6	Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w

Primary Outcome Measures

Name	Time	Method
Desease free Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 years

Trial Locations

Locations (1)

First affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China