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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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuncell-LC group | Experimental | Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated T lymphocyte | Biological | Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | Every 2 months from the baseline, up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Every visit, up to 16 weeks |
| Time to Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siyoung Song, MD, PhD | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei medical center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24916038 | Derived | 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. |
| Label | URL |
|---|---|
| Research paper | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immuncell-LC Group | Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immuncell-LC Group | Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 2 months from the baseline, up to 16 weeks |
|
1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immuncell-LC Group | Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment | Regarded as definitely not related to therapy by investigators. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moonjae Chung, MD | Yonsei university | 82-2-2228-2274 | MJCHUNG@yuhs.ac |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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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.
| 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. | 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. | Every one month from the baseline, up to 16 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG-PS | Eastern Cooperative Oncology Group performance status (ECOG-PS) is used by researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. "0"-Fully active, able to carry on all pre-disease performance without restriction "1"-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature "2"-Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours | Number | participants |
|
| Duration since diagnosis | Median | Full Range | months |
|
| Period of prior chemotherapy | Median | Full Range | months |
|
| Site of metastasis | Number | participants |
|
Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour. |
|
|
| Secondary | 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). | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Median | 95% Confidence Interval | weeks | Every visit, up to 16 weeks |
|
|
|
| Secondary | 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. | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Median | 95% Confidence Interval | weeks | Every 2 months from the baseline, up to 16 weeks |
|
|
|
| Secondary | 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. | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Every one month from the baseline, up to 16 weeks |
|
|
|
|
| Secondary | 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. | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Every one month from the baseline, up to 16 weeks |
|
|
|
| Primary | 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. | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Number | number of participants | Every 2 months from the baseline, up to 16 weeks |
|
|
|
| Primary | 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. | Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population. | Posted | Number | number of participants | Every 2 months from the baseline, up to 16 weeks |
|
|
|
| 7 |
| 20 |
| 20 |
| 20 |
|
| Ascite | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
|
| Physical functioning at last visit |
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| Role functioning at baseline |
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| Role functioning at last visit |
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| Emotional functioning at baseline |
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| Emotional functioning at last visit |
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| Cognitive functioning at baseline |
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| Cognitive functioning at last visit |
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| Social functioning at baseline |
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| Social functioning at last visit |
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| Fatigue at baseline |
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| Fatigue at last visit |
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| Nausea/vomiting at baseline |
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| Nausea/vomiting at last visit |
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| Pain at baseline |
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| Pain at last visit |
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| Dyspnea at baseline |
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| Dyspnea at last visit |
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| Constipation at baseline |
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| Constipation at last visit |
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| Diarrhea at baseline |
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| Diarrhea at last visit |
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| Insomnia at baseline |
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| Insomnia at last visit |
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| Appetite loss at baseline |
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| Appetite loss at last visit |
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| Financial difficulties at baseline |
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| Financial difficulties at last visit |
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| Title | Measurements |
|---|---|
|
| Gastrointestinal at last visit |
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| Jaundice at baseline |
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| Jaundice at last visit |
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| Body image at baseline |
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| Body image at last visit |
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| Altered bowel habit at baseline |
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| Altered bowel habit at last visit |
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| Health satisfaction at baseline |
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| Health satisfaction at last visit |
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| Sexuality scale at baseline |
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| Sexuality scale at last visit |
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| Bloated abdomen at baseline |
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| Bloated abdomen at last visit |
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| Taste changes at baseline |
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| Taste changes at last visit |
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| Indigestion at baseline |
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| Indigestion at last visit |
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| Flatulence at baseline |
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| Flatulence at last visit |
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| Weight loss at baseline |
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| Weight loss at last visit |
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| Decreased muscle strength at baseline |
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| Decreased muscle strength at last visit |
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| Dry mouth at baseline |
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| Dry mouth at last visit |
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| Treatment side effects at baseline |
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| Treatment side effects at last visit |
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| Fear for future health at baseline |
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| Fear for future health at last visit |
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| Ability to plan ahead at baseline |
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| Ability to plan ahead at last visit |
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| Average pain at baseline |
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| Average pain at last visit |
|