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

NCT ID: NCT03199807

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2021-07-20

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.

Conditions

HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NRT + radiotherapy

HCC received NRT and radiotherapy

Group Type: EXPERIMENTAL

NRT

Intervention Type: BIOLOGICAL

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.

Radiotherapy

Intervention Type: RADIATION

Radiotherapy of the major mass by dose of 5Gy/F \* 10F

Interventions

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.

Intervention Type: BIOLOGICAL

Radiotherapy

Radiotherapy of the major mass by dose of 5Gy/F \* 10F

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Zhengyun Zou

M.D, Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baorui Liu, M.D & Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University

Central Contacts

Baorui Liu, M.D & Ph.D

Role: CONTACT

baoruiliu@nju.edu.cn

+025-83106666 ext. 61331

Jie Shen, M.D & Ph.D

Role: CONTACT

shenjie2008nju@163.com

+025-83106666 ext. 61331

References

Liu C, Shao J, Dong Y, Xu Q, Zou Z, Chen F, Yan J, Liu J, Li S, Liu B, Shen J. Advanced HCC Patient Benefit From Neoantigen Reactive T Cells Based Immunotherapy: A Case Report. Front Immunol. 2021 Jul 13;12:685126. doi: 10.3389/fimmu.2021.685126. eCollection 2021.

Reference Type: DERIVED

PMID: 34326839 (View on PubMed)

Other Identifiers

Nanjing DrumTower Hospital

Identifier Type: -

Identifier Source: org_study_id