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

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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

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.

Condition or disease Intervention/treatment Phase
HCC Biological: NRT Radiation: Radiotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: NRT+radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IB/II Study of Personalized New Antigen Reactive Immune Cells (NRT) Combined With Radiotherapy for Advanced Hepatocellular Carcinoma Patients
Estimated Study Start Date : July 20, 2017
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 20, 2021

Arm Intervention/treatment
Experimental: NRT + radiotherapy
HCC received NRT and radiotherapy
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




Primary Outcome Measures :
  1. Number of participants with Adverse Events [ Time Frame: up to 6 months ]
    using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 3, 6 and 12 months ]
    Response Rate(RR) will be evaluated according Response Evaluation Criteria

  2. 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

  3. 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


Other Outcome Measures:
  1. 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)

  2. 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



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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:

  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.

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): NCT03199807


Contacts
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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

Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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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

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Responsible Party: Zhengyun Zou, M.D, Ph.D, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03199807     History of Changes
Other Study ID Numbers: Nanjing DrumTower Hospital
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhengyun Zou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
HCC
NRT
TOMO radiotherapy