Status:
COMPLETED
Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer
Lead Sponsor:
Yonsei University
Conditions:
Advanced Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Cholangiocarcinoma refers to bile duct cancer (bile duct cancer) and gallbladder cancer that develop in the gallbladder. According to the data from National Cancer Information Center in 2013, the inci...
Detailed Description
Cholangiocarcinoma refers to bile duct cancer (bile duct cancer) and gallbladder cancer that develop in the gallbladder. According to the data from National Cancer Information Center in 2013, the inci...
Eligibility Criteria
Inclusion
- patients with pathologically proven biliary tract cancer (gallbladder cancer, cholangiocarcinoma),
- patients with refractory disease after chemotherapy and/or patients who have difficulty with chemotherapy due to side effects of chemotherapy
- 18y≤age≤75y
- ECOG performance status (ECOG-PS) ≤2
- Patients who meet the following conditions; 1)ANC ≥ 1,500/μL, 2) Hemoglobin) ≥ 10 g/dL, 3) PLT \> 100,000/ μL, 4) Serum BUN \& Creatinine ≤ 1.5 x ULN, 5) AST \& ALT ≤ 2.5 x ULN, 6) Bilirubin ≤ 3mg/L
- Informed consent
Exclusion
- Immune deficiency or autoimmune disease that can be exacerbated by immunotherapy
- Pregnancy
- Patients who have a history of other malignancies except skin cancer, local prostate cancer or cervical intraepithelial neoplasm within 5 years before the start of this study
- Serious allergic history, psychological disease
- Breast feeding or Patients planning pregnancy
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03358849
Start Date
October 17 2017
End Date
September 27 2018
Last Update
January 16 2019
Active Locations (1)
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1
Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea, 03722