Know Cancer

forgot password

Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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should be withdrawn to make a study drug at least 2 weeks before administration.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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiological test should be operated by CT or MRI

Outcome Time Frame:

Every 2 months from the baseline

Safety Issue:


Principal Investigator

Siyoung Song, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University


Korea: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

December 2010

Related Keywords:

  • Pancreatic Cancer
  • advanced pancreatic cancer
  • Pancreatic Neoplasms