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Bioinformation Therapy for Liver Cancer

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ClinicalTrials.gov Identifier: NCT03239158
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Shengxin Biotechnology Institute, Beijing
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE September 2, 2017
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Relief degree of tumors [ Time Frame: 3 months ]
It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03239158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
  • Progress free survival(PFS) [ Time Frame: 1 year ]
    The duration between treatment and cancer recurrence
  • Overall survival(OS) [ Time Frame: 3 years ]
    The duration between treatment and patient pass away
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • Progress free survival(PFS) [ Time Frame: 1 year ]
  • Overall survival(OS) [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioinformation Therapy for Liver Cancer
Official Title  ICMJE Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Liver Cancer
Brief Summary The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable liver cancer.
Detailed Description By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver, Cancer of, Non-Resectable
Intervention  ICMJE
  • Device: Cancer ablation
    Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
    Other Name: Cryoablation or irreversible electroporation
  • Drug: Life information rehabilitation therapy
    Each treatment: one bottle solution each day, consecutive 3 months, oral administration
    Other Name: "Qilisheng" Immunoregulatory Oral Solution
Study Arms  ICMJE
  • Active Comparator: Cancer ablation
    In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
    Intervention: Device: Cancer ablation
  • Active Comparator: Life information rehabilitation therapy
    In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
    Intervention: Drug: Life information rehabilitation therapy
  • Experimental: Combination therapy
    In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
    Interventions:
    • Device: Cancer ablation
    • Drug: Life information rehabilitation therapy
  • No Intervention: Control
    In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2, 2018
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
  • Body tumor 1-6, with at least one tumor length > 2 cm
  • KPS ≥ 70, lifespan > 6 months
  • Platelet count ≥ 80×109/L,white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 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 NCT03239158
Other Study ID Numbers  ICMJE Bioinformation-liver
Has Data Monitoring Committee Not Provided
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 Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Shengxin Biotechnology Institute, Beijing
Investigators  ICMJE Not Provided
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date August 2017

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