Clinical trial · Interventional
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.
Safety and Effect Assessment of TACE in Combination With Autologous PD-1 Knockout Engineered T Cells by Percutaneous Infusion in the Paitents With Advanced Hepatocellular Carcinoma.
NCT04417764CI-TRIAL-00063821unknownPhase 1ClinicalTrials.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)
This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes.
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 knockout engineered T cells | Biological | — | UNRESOLVED |
| Transcatheter arterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE combined PD-1 knockout T cell treatment
- interventionNames
- Procedure: Transcatheter arterial chemoembolization
- Biological: PD-1 knockout engineered T cells
Primary outcomes (1)
- measure
- Incidence of Adverse Events
- timeFrame
- up to 2 years
- description
- Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.
Secondary outcomes (5)
- measure
- Response Rate
- timeFrame
- up to 12 months
- description
- To evaluate the objective response rate (ORR) ,refers to the proportion of patients whose tumors shrink to a certain extent and remain unchanged for a certain period of time, including patients with CR+PR.Tumors are assessed at baseline, the 8th week, the 16th week,the 24th week, and once every 12 weeks during the treatment and follow-up period per RECIST1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with unresectable hepatocellular carcinoma; 2. More than 18 years old; 3. Patients diagnosed with hepatocellular carcinoma by histopathology or imagings; 4. Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points; 5. Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis; 6. Other organs of the whole body function well; 7. Sign the informed consent; 8. Passed the review by the ethics committee. Exclusion Criteria: 1. Less than 18 or more than 70 years old; 2. Lack of autonomous decision-making ability; 3. ECOG score \>2, cachexia or multiple organ failure; 4. Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months. 5. Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant; 6. Patients with severe autoimmune diseases; Iodine contrast agent allergy; High allergic constitution; 7. The main portal vein was completely blocked by cancer embolism, with little collateral vascular formation; 8. Severe infection; AIDS, syphilis infection; 9. T cell lymphoma; 10. Patients with mental illness, severe trauma or other stress conditions; 11. Pregnant or nursing women; 12. Abnormal peripheral blood routine detection; 13. Failing to comply with the study protocol to complete the diagnosis and treatment project; Failed ethics committee review.
References
Publications (0)
Data not yet available
No reference posted for this study.