Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer
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 participate in the clinical trial by signing a written consent, only
appropriate subjects, who meet the criteria on the examinations and tests, will undergo this
clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml
should be withdrawn to make a study drug at least 2 weeks before administration. Subjects
should visit to hospital according to the protocol and receive a study drug. Therapeutic
response rate, overall survival rate, time to progression and the quality of life should be
investigated.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Radiological test should be operated by CT or MRI
Every 2 months from the baseline
Yes
Siyoung Song, MD, PhD
Principal Investigator
Yonsei University
Korea: Food and Drug Administration
ILC-IIT-01
NCT00965718
September 2009
December 2010
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