Clinical trial · Interventional
Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC
Phase IB/II Study of Personalized New Antigen Reactive Immune Cells (NRT) Combined With Radiotherapy for Advanced Hepatocellular Carcinoma Patients
NCT03199807CI-TRIAL-00028296LCRAI-1unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NRT | Biological | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NRT + radiotherapy
- description
- HCC received NRT and radiotherapy
- interventionNames
- Biological: NRT
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Number of participants with Adverse Events
- timeFrame
- up to 6 months
- description
- using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Secondary outcomes (3)
- measure
- Response Rate
- timeFrame
- 3, 6 and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLiu 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. PMID 34326839