Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity

Zhejiang University1 site in 1 countryNovember 1, 2017

ConditionsHepatocellular Carcinoma

InterventionsmFOLFOX6 Individualized Chemotherapy

DrugsIndividualized Chemotherapy mFOLFOX6

Overview

Phase: Phase 2
Intervention: mFOLFOX6
Conditions: Hepatocellular Carcinoma
Sponsor: Zhejiang University
Locations: 1
Primary Endpoint: Desease free Survival
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2017

End Date

December 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang University

Responsible Party

Principal Investigator

Weijia Fang, MD

Director

Zhejiang University

Eligibility 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.

Arms & Interventions

mFOLFOX6

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

Intervention: mFOLFOX6

Individualized Chemotherapy

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

Intervention: Individualized Chemotherapy