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Tests treatment safety and results for Pancreatic Ductal Adenocarcinoma
Official title Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT04969731
What this study is testing
What is Immuncell-LC?
Immuncell-LC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Also referred to as Autologous activated T lymphocyte.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- Age \>/=20 years old, \</=80 years old.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that fulfill the following requirements:
- Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed at least two weeks after the resection...
- Noncancerous ascites.
- No evidence of distant metastasis (such as liver, peritoneum)
You likely can't join if
- Received anticancer therapy including chemotherapy, biological therapy, immunotherapy, hormone therapy, radiation therapy, and other anti-cancer...
- Measurable lesions identified in the pancreas after surgery.
- Known history at the screening as defined below.
- Confirmed cases of acquired immunodeficiency, which can be exacerbated by immunotherapy.
- History of autoimmune diseases that can be exacerbated by immunotherapy. (e.g. rheumatoid arthritis, systemic lupus, vascular inflammation, multiple...
- Active hepatitis B or hepatitis C virus infection confirmed.
See the full eligibility criteria
- Age \>/=20 years old, \</=80 years old.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that fulfill the following requirements:
- Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed at least two weeks after the resection based on the baseline, up to 12 weeks.
- Noncancerous ascites.
- No evidence of distant metastasis (such as liver, peritoneum)
- No evidence of distant metastasis in other distant abdominal or extra-abdominal organs
- Scheduled to be given gemcitabine alone as postoperative adjuvant chemotherapy
- Eastern Cooperative Oncology Group-performance status (ECOG-PS) 0 - 2
- Life expectancy is at least 12 weeks.
- Adequate organ and marrow function at the screening and baseline as defined below:
- Absolute neutrophil count ≥ 1,500/μL
- Hemoglobin level ≥ 9 g/dL
- Platelet count ≥ 100,000/μL
- BUN, serum creatinine ≤ 1.5 × institutional upper limit of normal (ULN)
- AST, ALT ≤ 2.5 × institutional upper limit of normal (ULN)
- PT (INR), activated partial thromboplastin time (aPTT) ≤ 1.5 × institutional upper limit of normal (ULN)
- Ability to understand and the willingness to sign a written informed consent document.
- Received anticancer therapy including chemotherapy, biological therapy, immunotherapy, hormone therapy, radiation therapy, and other anti-cancer treatments. Note: Neo-adjuvant therapy for pancreatic cancer is allowed.
- Measurable lesions identified in the pancreas after surgery.
- Known history at the screening as defined below.
- Confirmed cases of acquired immunodeficiency, which can be exacerbated by immunotherapy.
- History of autoimmune diseases that can be exacerbated by immunotherapy. (e.g. rheumatoid arthritis, systemic lupus, vascular inflammation, multiple sclerosis, adolescent-induced insulin-dependent diabetes, T-cell...
- Active hepatitis B or hepatitis C virus infection confirmed.
- Human immunodeficiency virus (HIV) antibody test results are positive during screening
- History of malignant tumors other than pancreatic cancer within five years of screening. Note: skin basal cell cancer/squamous cell cancer, local prostate cancer, thyroid papillary cancer or cervical epithelial cancer...
- Known associated disease at the screening as defined below.
- Severe nephropathy: estimated glomerular filtration rate (eGFR)‡ \<30 mL/min/1.73 m2
- Chest X-ray shows epileptic pneumonia or pulmonary fibrosis with clear, clinical symptoms.
- Severe infections or other uncontrolled active infectious diseases requiring the administration of antibiotics, antibacterial drugs, antifungal drugs, antiviral drugs, etc. that may affect safety and validity evaluation...
- Holder of thromboembolic disease or bleeding diatheses
- Those who are deemed unfit to participate in clinical trials because they are not controlled or require treatment (e.g., heart disease, pulmonary dysfunction, renal dysfunction, low blood pressure, hypertension, bone...
- Received Immuncell-LC, Natural Killer (NK) cell therapy or other cell therapy drugs within three years prior to screening.
- Anaphylaxis to the main ingredient or sub-brothers of Immuncell-LC or Gemcitabine
- Patients who cannot collect blood for manufacturing Immuncell-LC depending on the investigator's judgment.
- Pregnant or lactating women
- Fertility women and men who are not willing to use appropriate contraception from screening to 24 weeks after final administration of Immuncell-LC and/or Gemgitabine
- Received or applied with another investigational products or investigational device within 4 weeks prior to signing a written informed consent document.
- Patients who are inappropriate or impossible to participate in the trial due to non-recovery of resection or prior chemotherapy depending on the investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Daehak-ro, Jongno-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Daehak-ro, Jongno-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.