Combining Immuncell-LC with Gemcitabine for Pancreatic Cancer Treatment

An Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Immuncell-LC Therapy Combined With Gemcitabine Versus Adjuvant Gemcitabine Single Therapy After Resection in Patients With Pancreatic Ductal Adenocarcinoma

This study is testing if adding a new immunotherapy called Immuncell-LC to the chemotherapy drug gemcitabine can help people with operable pancreatic cancer do better than with gemcitabine alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: GC Cell Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Seoul, Daehak-ro, Jongno-gu)
• Trial ID: NCT04969731 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial investigates the safety and efficacy of Immuncell-LC, an immunotherapy, in combination with gemcitabine, a chemotherapy drug, for patients with resectable pancreatic ductal adenocarcinoma. Participants who have undergone surgical resection will be randomly assigned to receive either the combination therapy or gemcitabine alone. The study aims to determine if the addition of Immuncell-LC improves outcomes compared to standard treatment. It is an open-label, multi-center trial designed to gather comprehensive data on the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 80 with resectable pancreatic ductal adenocarcinoma who have undergone surgery and are scheduled for adjuvant gemcitabine therapy.

Not a fit: Patients with distant metastasis or those who have not undergone adequate surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with pancreatic cancer after surgery.

How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy for various cancers, suggesting potential success for this approach in pancreatic cancer.

Eligibility criteria

Inclusion Criteria:

1. Age \>/=20 years old, \</=80 years old.
2. 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
3. Eastern Cooperative Oncology Group-performance status (ECOG-PS) 0 - 2
4. Life expectancy is at least 12 weeks.
5. 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)
6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. 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.
2. Measurable lesions identified in the pancreas after surgery.
3. 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 lymphoma, etc.)
   * 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 can be participated even if 5 years have passed since successful treatment.
4. 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 during clinical trials, as determined by the tester.
   * 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 marrow inhibition, liver metastasis, hepatitis, history of alcoholism, myocardial infarction, etc.)
5. Received Immuncell-LC, Natural Killer (NK) cell therapy or other cell therapy drugs within three years prior to screening.
6. Anaphylaxis to the main ingredient or sub-brothers of Immuncell-LC or Gemcitabine
7. Patients who cannot collect blood for manufacturing Immuncell-LC depending on the investigator's judgment.
8. Pregnant or lactating women
9. 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
10. Received or applied with another investigational products or investigational device within 4 weeks prior to signing a written informed consent document.
11. 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.

Where this trial is running

Seoul, Daehak-ro, Jongno-gu

• Seoul National University Hospital — Seoul, Daehak-ro, Jongno-gu, South Korea (Recruiting)

Study contacts

• Principal investigator: Sang Hyub Lee — Seoul National University Hospital

Conditions Pancreatic Ductal Adenocarcinoma; Adjuvant Therapy; Immuncell-LC; Gemcitabine; ILC-P3-PAN; Pancreatic Cancer