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

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ClinicalTrials.gov Identifier: NCT02580253
Recruitment Status : Unknown
Verified June 2017 by Weijia Fang, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2015
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Weijia Fang, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Individualized Chemotherapy Drug: mFOLFOX6 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individualized Chemotherapy
Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
Drug: Individualized Chemotherapy
Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)

Active Comparator: mFOLFOX6
Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w
Drug: mFOLFOX6
Oxaliplatin,Fluorouracil




Primary Outcome Measures :
  1. Desease free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580253


Contacts
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Contact: Fang Weijia, Doctor +86-13758211655 weijiafang@zju.edu.cn

Locations
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China, Zhejiang
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
Zhejiang University

Publications:
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Responsible Party: Weijia Fang, Director, Zhejiang University
ClinicalTrials.gov Identifier: NCT02580253     History of Changes
Other Study ID Numbers: ZYYYMedOncoLT02
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenosine
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents