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Pancreatic CancerPhase 2NCT00965718

Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer

A Phase 2 study testing Activated T lymphocyte in people with Pancreatic Cancer, run by GC Cell Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Activated T lymphocyte
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
Sep 2009to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug.
  • Patient aged 18 to 75
  • Patient with pathologically-confirmed, advanced pancreatic cancer
  • ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
  • Patient with anticipated survival period of more than 3 months
  • Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
  • Patient whose blood test, renal function test and liver function test results meet the following conditions.

Who cannot join

  • Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.)
  • Confirmed immunodeficient patient
  • Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study
  • Patient who has received systemic anti-angiogenic agent
  • Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
  • Obvious myocardial failure or uncontrolled arterial hypertension
Show all 10Show fewer
  • Patient who has experienced serious allergy (judged by the investigator)
  • Patient with serious psychological disease (judged by the investigator)
  • Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
  • Patient who has participated in another clinical trial within the last 4 weeks of the start of study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei medical center

    Seoul

Other trials in South Korea

About this study

Official title: Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer

Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer

Read the detailed description

This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer.

If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression and the quality of life should be investigated.

Being tested
Activated T lymphocyte
Keywords
advanced 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.

  • Activated T lymphocyteBiological

    Also called Immuncell-LC

    Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.

Study groups in NCT00965718
Study groupRoleWhat they receive
Immuncell-LC groupExperimentalIntravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.
Receives: Biological: Activated T lymphocyte

What is being measured

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

  1. Disease Control Rate

    Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

    Disease control rate = CR or PR or SD patients / ITT population *100

    Measured: Every 2 months from the baseline, up to 16 weeks

  2. Stable Disease(SD)

    Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.

    Measured: Every 2 months from the baseline, up to 16 weeks

  3. Progressive Disease(PD)

    Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.

    Measured: Every 2 months from the baseline, up to 16 weeks

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS was calculated from the date of enrollment until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).

    Measured: Every visit, up to 16 weeks

  2. Time to Progression

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.

    Measured: Every 2 months from the baseline, up to 16 weeks

  3. Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)

    QLQ-C30 constitutes a functional scale(physical, role, emotional, cognitive, and social functioning), symptom scores scale(fatigue, nausea/vomiting, pain, dyspnea, constipation, diarrhea, insomnia, appetite loss, financial difficulties), and global QoL scale. With the scores of all scales ranging from 0 to 100, a higher score indicates a better functional scale and a better global QoL scale as well as a worse symptom scores scale.

    Measured: Every one month from the baseline, up to 16 weeks

  4. Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)

    QLQ-PAN26 consists of questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.

    Measured: Every one month from the baseline, up to 16 weeks

Timeline

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

  1. First posted26 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2010
  4. Study completionDec 2010

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00965718
Sponsor's protocol ID
ILC-IIT-01
Status last verified
Jul 2023
First submitted
24 Aug 2009
Last updated
19 Jul 2023
Data monitoring committee
No

Publications

  • Chung MJ, Park JY, Bang S, Park SW, Song SY. Phase II clinical trial of ex vivo-expanded cytokine-induced killer cells therapy in advanced pancreatic cancer. Cancer Immunol Immunother. 2014 Sep;63(9):939-46. doi: 10.1007/s00262-014-1566-3. Epub 2014 Jun 12.

    PubMed 24916038

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Activated T lymphocyte in people with Pancreatic Cancer, 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 19 Jul 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (time frame: Every 2 months from the baseline, up to 16 weeks). The study lists 3 primary outcomes in all. 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 NCT00965718, 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 19 Jul 2023.

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