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Pancreatic Ductal AdenocarcinomaPhase 3NCT04969731

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

A Phase 3 study testing Immuncell-LC and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by GC Cell Corporation at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Immuncell-LC and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
1 siteSouth Korea
Study dates
7 Sep 2021to Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, Daehak-ro, Jongno-gu, 03080

    Site Public Contact, 82-02-2072-0694, snuhirb@gmail.com

    Sang Hyub Lee

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description

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

Being tested
Immuncell-LC, Gemcitabine
Keywords
Adjuvant Therapy, Immuncell-LC, Gemcitabine, ILC-P3-PAN, Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immuncell-LCDrug

    Also called Autologous activated T lymphocyte

    IV

  • GemcitabineDrug

    IV

Study groups in NCT04969731
Study groupRoleWhat they receive
Immuncell-LC/GemcitabineExperimentalPatients 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)
Receives: Drug: Immuncell-LC; Drug: Gemcitabine
GemcitabineActive comparatorPatients will receive 6 cycles Gemcitabine alone (1000 mg/m2 on Days 1, 8, 15, 28-day a cycle)
Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to approximately 36 months after Last Patient In

Secondary outcomes (5)

  1. Overall survival (OS)

    Overall survival is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 36 months after Last Patient In

  2. 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

    Measured: Up to approximately 36 months after Last Patient In

  3. Carbohydrate antigen 19-9 level

    Carbohydrate antigen 19-9 level

    Measured: Up to approximately 36 months after Last Patient In

  4. 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.

    Measured: Up to approximately 36 months after Last Patient In

  5. 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.

    Measured: Up to approximately 36 months after Last Patient In

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start7 Sep 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04969731
Sponsor's protocol ID
ILC-P3-PAN
Status last verified
Nov 2021
First submitted
6 Jul 2021
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37078953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immuncell-LC and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by GC Cell Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free survival (RFS) by independent review (time frame: Up to approximately 36 months after Last Patient In). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04969731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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