Phase IB/II study of personalized new antigen reactive immune cells (NRT) combined with radiotherapy for advanced hepatocellular carcinoma patients

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16010025

Enrollment

Unknown

Registered

2016-11-27

Start date

2016-11-26

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

None: radiotherapy combined with NRT immunotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
OS;PFS;ORR;Safety;	—

Secondary

Measure	Time frame
Tumor marker;Immune indexes;	—

Countries

China

Contacts

Public ContactBaorui Liu

The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital

baoruiliu@nju.edu.cn+86 025 83106666-61331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026