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Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC (LCRAI-1)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199807
Recruitment Status : Not yet recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Zhengyun Zou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date  ICMJE June 18, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date June 27, 2017
Estimated Study Start Date  ICMJE July 20, 2017
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2017)
Number of participants with Adverse Events [ Time Frame: up to 6 months ]
using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2017)
  • Response Rate [ Time Frame: 3, 6 and 12 months ]
    Response Rate(RR) will be evaluated according Response Evaluation Criteria
  • Progression free survival (PFS) [ Time Frame: 3, 6, 9 and 12 months ]
    the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented
  • Overall Survival (OS) [ Time Frame: At 6, 12 and 18 months ]
    the duration is measured from the time of treatment to the time of death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2017)
  • Th1/Th2 change in the peripheral blood [ Time Frame: At baseline,and 1 month, 3 months and 6 months ]
    cytokines are measured by flow cytometry(FCM)
  • Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens [ Time Frame: At baseline,and 1 month, 3 months and 6 months ]
    Interferon-gama change of PBMC cells by ELISPOT
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC
Official Title  ICMJE Phase IB/II Study of Personalized New Antigen Reactive Immune Cells (NRT) Combined With Radiotherapy for Advanced Hepatocellular Carcinoma Patients
Brief Summary The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Detailed Description Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related death worldwide. The resection rate for HCC is approximately 10%-30% and the overall prognosis is very poor with a 5-year survival rate of 5%-6%. The recurrence rate is high after radical resection. In addition to surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), microwave ablation, cryoablation, radioactive seeds implantation, high-intensity-focused ultrasound, radiation therapy, chemotherapy and targeted drugs are available for patients with unresectable tumors; however, the efficacy of these treatments are limited and long-term prognosis in the patients is still poor. Moreover, due to serious side effects induced by treatments such as TACE, chemotherapy and targeted drugs, it may not be possible for patients to continue receiving these therapies. The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
NRT+radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HCC
Intervention  ICMJE
  • Biological: NRT
    Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory. NRTs 0.5~1 x 10^10, will be i.v.Q3 weeks for total 4-6 doses.
  • Radiation: Radiotherapy
    Radiotherapy of the major mass by dose of 5Gy/F * 10F
Study Arms  ICMJE Experimental: NRT + radiotherapy
HCC received NRT and radiotherapy
Interventions:
  • Biological: NRT
  • Radiation: Radiotherapy
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 20, 2021
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female or male aged 18 years and over, but no more than 75 years;
  2. Histologic or cytologic confirmation of advanced hepatocellular carcinoma;
  3. Patients with measurable lesions but can not be treated with surgery;
  4. Patients with two or over measurable lesions;
  5. ECOG≤0-2, Child-pugh A-B;
  6. Patients had not received systemic venous chemotherapy ever before;
  7. Hematology Index;
  8. Neutrophile granulocyte greater than 1.5×10^9/L;
  9. Hemoglobin greater than 10g/dL;
  10. Platelet greater than 90×10^9/L;
  11. Biochemical index
  12. Serum bilirubin not greater than 1.5x upper limit of reference range (ULN)
  13. ALT or AST not greater than 1.5x ULN
  14. Creatinine clearance no less than 60ml/min;
  15. Negative pregnancy test for women of childbearing potential;
  16. Provision of informed consent;
  17. Be able to follow the research program and follow up process;
  18. Expected survival time 3 months or more.

Exclusion Criteria:

  1. Chemotherapy with experimental drug within 3 months before the start of study therapy;
  2. Have at least another primary malignant tumor;
  3. Active infection with bacterial or fungal infection;
  4. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group;
  5. Women who are pregnant or breast feeding;
  6. Drug abuse, clinical or psychological or social factors which will influence the informed. consent or the study implementation;
  7. May be allergic to immunotherapy;
  8. Radiotherapy and immunotherapy may not be implemented due to social or geographical factors;
  9. Weight loss greater 10% within 6 weeks before the start of study therapy;
  10. influence the safety or compliance of the patients.
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: Baorui Liu, M.D & Ph.D +025-83106666 ext 61331 baoruiliu@nju.edu.cn
Contact: Jie Shen, M.D & Ph.D +025-83106666 ext 61331 shenjie2008nju@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199807
Other Study ID Numbers  ICMJE Nanjing DrumTower Hospital
Has Data Monitoring Committee Yes
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
Plan to Share IPD: Undecided
Responsible Party Zhengyun Zou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Baorui Liu, M.D & Ph.D The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date June 2017

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