Phase 2
N=20
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00965718 ↗Enrolled (actual)
20
Serious AEs
35.0%
Results posted
Sep 2014
Primary outcome: Primary: Disease Control Rate — 25 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Activated T lymphocyte (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GC Cell Corporation
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate |
25 | — |
| PRIMARY Stable Disease(SD) |
4 | — |
| PRIMARY Progressive Disease(PD) |
12 | — |
| SECONDARY Overall Survival (OS) |
26.6 | — |
| SECONDARY Time to Progression |
11 | — |
| SECONDARY Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30) |
53.65; 40.63; 73.75; 69.58; 76.04; 59.38 | 0.123 |
| SECONDARY Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire) |
77.08; 60.42; 78.13; 63.54; 93.75; 87.50 | — |
Summary
Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
Eligibility Criteria
Inclusion Criteria
- 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.
- Patient aged 18 to 75
- Patient with pathologically-confirmed, advanced pancreatic cancer
- ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
- Patient with anticipated survival period of more than 3 months
- Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
- Patient whose blood test, renal function test and liver function test results meet the following conditions.
Exclusion Criteria
- 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.)
- Confirmed immunodeficient patient
- 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
- Patient who has received systemic anti-angiogenic agent
- Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
- Obvious myocardial failure or uncontrolled arterial hypertension
- Patient who has experienced serious allergy (judged by the investigator)
- Patient with serious psychological disease (judged by the investigator)
- Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
- Patient who has participated in another clinical trial within the last 4 weeks of the start of study
Data sourced from ClinicalTrials.gov (NCT00965718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.