Status:
COMPLETED
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Lead Sponsor:
GC Cell Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
Detailed Description
This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer. If subjects agree to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00965718
Start Date
September 1 2009
End Date
December 1 2010
Last Update
July 19 2023
Active Locations (1)
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1
Yonsei medical center
Seoul, South Korea