A Phase 2 interventional study of Activated T lymphocyte in Pancreatic Cancer, sponsored by GC Cell Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by GC Cell Corporation · Phase 2, Interventional, and Treatment
Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration.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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 20 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →GC Cell Corporation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour.
Biological: Activated T lymphocyte
Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour.
Also known as: Immuncell-LC
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
Time frame: Every 2 months from the baseline, up to 16 weeks
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.
Time frame: Every 2 months from the baseline, up to 16 weeks
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.
Time frame: Every 2 months from the baseline, up to 16 weeks
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).
Time frame: Every visit, up to 16 weeks
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.
Time frame: Every 2 months from the baseline, up to 16 weeks
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.
Time frame: Every one month from the baseline, up to 16 weeks
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.
Time frame: Every one month from the baseline, up to 16 weeks
Patients with advanced pancreatic cancer who showed disease progression during gemcitabine-based chemotherapy were enrolled in this study. Twenty patients were enrolled between September 2009 and September 2010.
| Milestone | Immuncell-LC Group |
|---|---|
| Started | 20 |
| Completed | 16 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 4 |
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
| percentage of participants | Immuncell-LC Group |
|---|---|
| Disease Control Rate | 25 (3.78 to 46.22) |
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).
| weeks | Immuncell-LC Group |
|---|---|
| Overall Survival (OS) | 26.6 (8.6 to 44.6) |
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.
| weeks | Immuncell-LC Group |
|---|---|
| Time to Progression | 11 (8.8 to 13.2) |
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.
| units on a scale | Immuncell-LC Group |
|---|---|
| Global health status at baseline | 53.65 ± 29.81 |
| Global health status at last visit | 40.63 ± 25.98 |
| Physical functioning at baseline | 73.75 ± 30.64 |
| Physical functioning at last visit | 69.58 ± 21.63 |
| Role functioning at baseline | 76.04 ± 32.76 |
| Role functioning at last visit | 59.38 ± 29.79 |
| Emotional functioning at baseline | 70.31 ± 20.41 |
| Emotional functioning at last visit | 61.98 ± 23.56 |
| Cognitive functioning at baseline | 71.88 ± 24.13 |
| Cognitive functioning at last visit | 68.75 ± 28.46 |
| Social functioning at baseline | 68.75 ± 20.97 |
| Social functioning at last visit | 55.21 ± 27.02 |
| Fatigue at baseline | 40.97 ± 24.59 |
| Fatigue at last visit | 50.69 ± 29.25 |
| Nausea/vomiting at baseline | 15.63 ± 25.44 |
| Nausea/vomiting at last visit | 16.67 ± 18.26 |
| Pain at baseline | 20.83 ± 25.46 |
| Pain at last visit | 45.83 ± 26.87 |
| Dyspnea at baseline | 10.42 ± 20.07 |
| Dyspnea at last visit | 27.08 ± 32.70 |
| Constipation at baseline | 16.67 ± 24.34 |
| Constipation at last visit | 29.17 ± 40.14 |
| Diarrhea at baseline | 8.33 ± 25.82 |
| Diarrhea at last visit | 8.33 ± 19.25 |
| Insomnia at baseline | 14.58 ± 20.97 |
| Insomnia at last visit | 43.75 ± 33.82 |
| Appetite loss at baseline | 31.25 ± 33.26 |
| Appetite loss at last visit | 43.75 ± 37.94 |
| Financial difficulties at baseline | 27.08 ± 30.35 |
| Financial difficulties at last visit | 31.25 ± 33.26 |
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.
| units on a scale | Immuncell-LC Group |
|---|---|
| Pancreatic pain at baseline | 77.08 ± 23.07 |
| Pancreatic pain at last visit | 60.42 ± 25.91 |
| Gastrointestinal at baseline | 78.13 ± 29.01 |
| Gastrointestinal at last visit | 63.54 ± 29.32 |
| Jaundice at baseline | 93.75 ± 11.98 |
| Jaundice at last visit | 87.50 ± 16.67 |
| Body image at baseline | 56.25 ± 38.91 |
| Body image at last visit | 56.25 ± 29.74 |
| Altered bowel habit at baseline | 79.17 ± 24.72 |
| Altered bowel habit at last visit | 61.46 ± 24.13 |
| Health satisfaction at baseline | 35.42 ± 24.25 |
| Health satisfaction at last visit | 34.38 ± 27.53 |
| Sexuality scale at baseline | 55.21 ± 39.78 |
| Sexuality scale at last visit | 54.17 ± 34.16 |
| Bloated abdomen at baseline | 35.42 ± 25.73 |
| Bloated abdomen at last visit | 54.17 ± 34.16 |
| Taste changes at baseline | 29.17 ± 29.50 |
| Taste changes at last visit | 43.75 ± 35.94 |
| Indigestion at baseline | 27.08 ± 34.89 |
| Indigestion at last visit | 41.67 ± 31.03 |
| Flatulence at baseline | 20.83 ± 23.96 |
| Flatulence at last visit | 33.33 ± 32.20 |
| Weight loss at baseline | 22.92 ± 33.82 |
| Weight loss at last visit | 27.08 ± 25.00 |
| Decreased muscle strength at baseline | 31.25 ± 30.96 |
| Decreased muscle strength at last visit | 43.75 ± 29.11 |
| Dry mouth at baseline | 25.00 ± 31.03 |
| Dry mouth at last visit | 45.83 ± 34.16 |
| Treatment side effects at baseline | 29.17 ± 36.26 |
| Treatment side effects at last visit | 39.58 ± 30.35 |
| Fear for future health at baseline | 52.08 ± 29.74 |
| Fear for future health at last visit | 58.33 ± 19.25 |
| Ability to plan ahead at baseline | 31.25 ± 33.26 |
| Ability to plan ahead at last visit | 52.08 ± 27.13 |
| Average pain at baseline | 1.13 ± 1.89 |
| Average pain at last visit | 3.19 ± 2.43 |
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.
| number of participants | Immuncell-LC Group |
|---|---|
| Stable Disease(SD) | 4 |
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.
| number of participants | Immuncell-LC Group |
|---|---|
| Progressive Disease(PD) | 12 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immuncell-LC Group | — | 7/20 (35%) | 20/20 (100%) |
| Event | Immuncell-LC Group |
|---|---|
| Abdominal painGastrointestinal disorders | 1/20 |
| AsciteGastrointestinal disorders | 1/20 |
| HaematemesisGastrointestinal disorders | 1/20 |
| IleusGastrointestinal disorders | 1/20 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/20 |
| DeathGeneral disorders | 1/20 |
| General physical health deteriorationGeneral disorders | 1/20 |
| Event | Immuncell-LC Group |
|---|---|
| VomitingGastrointestinal disorders | 7/20 |
| NauseaGastrointestinal disorders | 7/20 |
| Abdominal painGastrointestinal disorders | 5/20 |
| DiarrhoeaGastrointestinal disorders | 5/20 |
| Age, Continuous(years) | Immuncell-LC Group |
|---|---|
| Median | 59.2 (41 to 69) |
| Sex: Female, Male(Participants) | Immuncell-LC Group |
|---|---|
| Female | 8 |
| Male | 12 |
| Region of Enrollment(participants) | Immuncell-LC Group |
|---|---|
| Korea, Republic of | 20 |
| ECOG-PS(participants) | Immuncell-LC Group |
|---|---|
| 0 | 12 |
| 1 | 7 |
| 2 | 1 |
| Duration since diagnosis(months) | Immuncell-LC Group |
|---|---|
| Median | 9.2 (3.8 to 94.6) |
| Period of prior chemotherapy(months) | Immuncell-LC Group |
|---|---|
| Median | 5.2 (2.0 to 13.9) |
| Site of metastasis(participants) | Immuncell-LC Group |
|---|---|
| Liver | 9 |
| Lung | 6 |
| Lymph node | 5 |
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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