Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Gemcitabine; Drug: Immuncell-LC

Detailed Description

Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial

• Study Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daehak-ro, Jongno-gu
    • Seoul, Daehak-ro, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Site Public Contact; Phone Number: 82-02-2072-0694; Email: snuhirb@gmail.com
      • Principal Investigator: Sang Hyub Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Immuncell-LC/Gemcitabine; Patients will receive 6 cycles Gemcitabine (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle) and Immuncell-LC 16 times during 60 weeks (4 treatments once a week, followed by 4 treatments every other week, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks)	Drug: Gemcitabine; IV; Drug: Immuncell-LC; IV; Other Names: Autologous activated T lymphocyte
ACTIVE_COMPARATOR: Gemcitabine; Patients will receive 6 cycles Gemcitabine alone (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle)	Drug: Gemcitabine; IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence free survival (RFS) by independent review	Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by independent reviewer	Up to approximately 36 months after Last Patient In

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival is defined as the time from randomization to death due to any cause.	Up to approximately 36 months after Last Patient In
Recurrence free survival (RFS) by investigator	Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by investigator	Up to approximately 36 months after Last Patient In
Carbohydrate antigen 19-9 level	Carbohydrate antigen 19-9 level	Up to approximately 36 months after Last Patient In
Quality of Life (QoL) EORTC QLQ-C30	The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	Up to approximately 36 months after Last Patient In
Quality of Life (QoL) EORTC QLQ-PAN26	The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). The answers range is the following: not at all - 1 point, a little - 2 points, quite a bit - 3 points, very much - 4 points. Minimum score is 26, maximum is 106. The higher total score represents the worse quality of life.	Up to approximately 36 months after Last Patient In

Collaborators and Investigators

• Sponsor: GC Cell Corporation
• Investigators: Principal Investigator: Sang Hyub Lee, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2021
• Primary Completion (ANTICIPATED): December 1, 2026
• Study Completion (ANTICIPATED): June 1, 2027

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (ACTUAL): July 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Gemcitabine; Pancreatic Cancer; Adjuvant Therapy; Immuncell-LC; ILC-P3-PAN
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: ILC-P3-PAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No