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Trial record 66 of 1198 for:    Adenosine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 17, 2015
First Posted Date  ICMJE October 20, 2015
Last Update Posted Date July 2, 2017
Estimated Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
Desease free Survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02580253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
Overall Survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation
Official Title  ICMJE Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Individualized Chemotherapy
    Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
  • Drug: mFOLFOX6
    Oxaliplatin,Fluorouracil
Study Arms  ICMJE
  • Experimental: Individualized Chemotherapy
    Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
    Intervention: Drug: Individualized Chemotherapy
  • Active Comparator: mFOLFOX6
    Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w
    Intervention: Drug: mFOLFOX6
Publications * Lin HS, Wan RH, Gao LH, Li JF, Shan RF, Shi J. Adjuvant chemotherapy after liver transplantation for hepatocellular carcinoma: a systematic review and a meta-analysis. Hepatobiliary Pancreat Dis Int. 2015 Jun;14(3):236-45. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02580253
Other Study ID Numbers  ICMJE ZYYYMedOncoLT02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weijia Fang, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhejiang University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP