Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC

HCC Clinical Trial

— LCRAI-1  

Official title:

Phase IB/II Study of Personalized New Antigen Reactive Immune Cells (NRT) Combined With Radiotherapy for Advanced Hepatocellular Carcinoma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03199807
• Other study ID #: Nanjing DrumTower Hospital
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 18, 2017
• Last updated: June 24, 2017
• Start date: July 20, 2017
• Est. completion date: July 20, 2021

Study information

• Verified date: June 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Baorui Liu, M.D & Ph.D
• Phone: +025-83106666
• Email: baoruiliu[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• HCC

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Th1/Th2 change in the peripheral blood	cytokines are measured by flow cytometry(FCM)	At baseline,and 1 month, 3 months and 6 months
Other	Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens	Interferon-gama change of PBMC cells by ELISPOT	At baseline,and 1 month, 3 months and 6 months
Primary	Number of participants with Adverse Events	using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients	up to 6 months
Secondary	Response Rate	Response Rate(RR) will be evaluated according Response Evaluation Criteria	3, 6 and 12 months
Secondary	Progression free survival (PFS)	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, 6, 9 and 12 months
Secondary	Overall Survival (OS)	the duration is measured from the time of treatment to the time of death	At 6, 12 and 18 months