Clinical trial · Interventional
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer
NCT00965718CI-TRIAL-00068082completedPhase 2Results postedClinicalTrials.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)
Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated T lymphocyte | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immuncell-LC group
- description
- Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour.
- interventionNames
- Biological: Activated T lymphocyte
Primary outcomes (3)
- measure
- Disease Control Rate
- timeFrame
- Every 2 months from the baseline, up to 16 weeks
- description
- Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Disease control rate = CR or PR or SD patients / ITT population \*100
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug. 2. Patient aged 18 to 75 3. Patient with pathologically-confirmed, advanced pancreatic cancer 4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score) 5. Patient with anticipated survival period of more than 3 months 6. Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy 7. Patient whose blood test, renal function test and liver function test results meet the following conditions. Exclusion Criteria: 1. Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.) 2. Confirmed immunodeficient patient 3. Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study 4. Patient who has received systemic anti-angiogenic agent 5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy 6. Obvious myocardial failure or uncontrolled arterial hypertension 7. Patient who has experienced serious allergy (judged by the investigator) 8. Patient with serious psychological disease (judged by the investigator) 9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period 10. Patient who has participated in another clinical trial within the last 4 weeks of the start of study
References
Publications (1)
- DERIVEDChung MJ, Park JY, Bang S, Park SW, Song SY. Phase II clinical trial of ex vivo-expanded cytokine-induced killer cells therapy in advanced pancreatic cancer. Cancer Immunol Immunother. 2014 Sep;63(9):939-46. doi: 10.1007/s00262-014-1566-3. Epub 2014 Jun 12. PMID 24916038