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

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Individualized Chemotherapy
mFOLFOX6
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized Chemotherapy

mFOLFOX6

Arm Description

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

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

Outcomes

Primary Outcome Measures

Desease free Survival

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
October 17, 2015
Last Updated
February 13, 2020
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02580253
Brief Title
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation
Official Title
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no patients enrolled
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized Chemotherapy
Arm Type
Experimental
Arm Description
Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
Arm Title
mFOLFOX6
Arm Type
Active Comparator
Arm Description
Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w
Intervention Type
Drug
Intervention Name(s)
Individualized Chemotherapy
Intervention Description
Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
Oxaliplatin,Fluorouracil
Primary Outcome Measure Information:
Title
Desease free Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
First affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26063023
Citation
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. doi: 10.1016/s1499-3872(15)60373-3.
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Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation

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