Actively Recruiting
Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
Led by GC Cell Corporation · Updated on 2021-11-22
408
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
PURPOSE: This phase III clinical trial evaluates the efficacy and safety of adjuvant Immuncell-LC therapy combined with gemcitabine versus adjuvant gemcitabine single therapy after R0 or R1 resection in patients with pancreatic ductal adenocarcinoma.
CONDITIONS
Official Title
Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 80 years old
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
- Underwent radical full resection (R0) or boundary resection (R1) surgery at least 2 weeks and up to 12 weeks before baseline
- No noncancerous ascites
- No distant metastasis in liver, peritoneum, or other abdominal or extra-abdominal organs
- Scheduled to receive gemcitabine alone as postoperative adjuvant chemotherapy
- Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate organ and marrow function including neutrophil count ≥ 1,500/µL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100,000/µL
- Kidney function (BUN, serum creatinine) ≤ 1.5 times institutional upper limit of normal (ULN)
- Liver enzymes (AST, ALT) ≤ 2.5 times ULN
- Blood clotting times (PT INR, aPTT) ≤ 1.5 times ULN
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Received anticancer therapy such as chemotherapy, biological therapy, immunotherapy, hormone therapy, radiation, except allowed neoadjuvant therapy for pancreatic cancer
- Measurable lesions in the pancreas after surgery
- History of acquired immunodeficiency or autoimmune diseases that could worsen with immunotherapy
- Active hepatitis B or C infection
- Positive HIV antibody test
- History of other malignant tumors within 5 years, except certain treated skin, prostate, thyroid, or cervical cancers
- Severe kidney disease with eGFR <30 mL/min/1.73 m2
- Chest X-ray showing epileptic pneumonia or pulmonary fibrosis with clinical symptoms
- Severe uncontrolled infections requiring treatment
- History of thromboembolic disease or bleeding disorders
- Uncontrolled or untreated significant heart, lung, kidney, or liver conditions
- Received Immuncell-LC, Natural Killer cell therapy, or other cell therapy within 3 years
- Allergic reactions to Immuncell-LC or Gemcitabine
- Inability to provide blood for Immuncell-LC manufacturing
- Pregnant or breastfeeding women
- Women and men not willing to use contraception from screening to 24 weeks after last treatment
- Participation in other investigational drug or device trials within 4 weeks
- Inability to participate due to incomplete recovery from surgery or prior chemotherapy as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Daehak-ro, Jongno-gu, South Korea, 03080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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