Clinical trial · Interventional
Clinical Trial of Autologous Tcm Immunotherapy in ICC
Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection
- 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 prime purpose of this trial is to evaluate the Progression Free survival and two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in intrahepatic cholangiocarcinoma (ICC) patients after radical resection. A secondary objective of the trial is to assess the long-term survival and safety of Tcm cellular immunotherapy and traditional therapy in ICC patients after radical resection. Patients will be randomized 1:1 either to the experimental group to receive autologous Tcm cellular immunotherapy and chemotherapy or to the control group (traditional therapy).
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous Tcm cellular immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- traditional therapy plus autologous Tcm cellular immunotherapy.
- interventionNames
- Biological: autologous Tcm cellular immunotherapy
- type
- NO_INTERVENTION
- label
- control group
- description
- traditional therapy alone, such as radiotherapy or chemotherapy.
Primary outcomes (2)
- measure
- Progression Free Survival
- timeFrame
- 24 months
- description
- The Progression Free Survival of combining autologous Tcm cellular immunotherapy and traditional therapy in ICC subjects after radical resection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial 2. Subjects treated with radical resection completely, and pathologically confirmed intrahepatic cholangiocarcinoma 3. Subjects with image examination confirmed complete response (CR) postoperatively 4. Age between 18 and 70 years old 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Normal hematopoietic function: White Blood Cell (WBC) ≥ 4×10\^9 /L Neutrophil ≥ 2×10\^9 /L Hemoglobin ≥ 90 g /L Platelets ≥ 100×10\^9 /L 7. Lymphocyte ≥ 0.7×10\^9 /L 8. Adequate Liver and kidney function Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 the upper limit of normal (ULN) for the institution Total bilirubin (TBIL) ≤ 1.5 the upper limit of ULN Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN Creatinine clearance ≥ 70 ml/min 9. Subjects without significant cardiovascular and lung disease Exclusion Criteria: 1. Subjects with recurrent intrahepatic cholangiocarcinoma 2. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation. 3. Subjects with severe abnormality of coagulation; 4. History or any evidence of hemorrhage. 5. Subjects with bone marrow transplant or severe leukopenia 6. Subjects with severe heart, liver or kidney diseases. 7. Subjects with severe infection or high fever. 8. Subjects with severe autoimmune diseases. 9. Subjects infected with HIV 10. Subjects combined with other malignancies 11. Subjects with T-cell lymphma or tumor
References
Publications (0)
Data not yet available