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

NCT04969731 | Recruiting Phase 3 DMC

• 1 other identifier: ILC-P3-PAN
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Ductal Adenocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival (OS)

  Up to approximately 36 months after Last Patient In

• Recurrence free survival (RFS) by investigator

  Up to approximately 36 months after Last Patient In

• Carbohydrate antigen 19-9 level

  Up to approximately 36 months after Last Patient In

• Quality of Life (QoL) EORTC QLQ-C30

  Up to approximately 36 months after Last Patient In

• Quality of Life (QoL) EORTC QLQ-PAN26

  Up to approximately 36 months after Last Patient In

Study Arms (2)

Immuncell-LC/Gemcitabine

EXPERIMENTAL

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: Immuncell-LC; Drug: Gemcitabine

Gemcitabine

ACTIVE COMPARATOR

Patients will receive 6 cycles Gemcitabine alone (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle)

Drug: Gemcitabine

Interventions

Immuncell-LC DRUG

IV

Also known as: Autologous activated T lymphocyte

Immuncell-LC/Gemcitabine

Gemcitabine DRUG

IV

Gemcitabine; Immuncell-LC/Gemcitabine

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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)

You may not qualify if:

• 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 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.
• 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.)
• Received Immuncell-LC, Natural Killer (NK) cell therapy or other cell therapy drugs within three years prior to screening.

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Daehak-ro, Jongno-gu, 03080, South Korea

RECRUITING

Related Publications (1)

• Choi JH, Nam GH, Hong JM, Cho IR, Paik WH, Ryu JK, Kim YT, Lee SH. Cytokine-Induced Killer Cell Immunotherapy Combined With Gemcitabine Reduces Systemic Metastasis in Pancreatic Cancer: An Analysis Using Preclinical Adjuvant Therapy-Mimicking Pancreatic Cancer Xenograft Model. Pancreas. 2022 Oct 1;51(9):1251-1257. doi: 10.1097/MPA.0000000000002176.

  PMID: 37078953 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sang Hyub Lee

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 21, 2021
• Study Start: September 7, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

KR (1)