Trial Outcomes & Findings for Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer (NCT NCT00965718)
NCT ID: NCT00965718
Last Updated: 2023-07-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Every 2 months from the baseline, up to 16 weeks
Results posted on
2023-07-19
Participant Flow
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.
Participant milestones
| Measure |
Immuncell-LC Group
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Immuncell-LC Group
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Immuncell-LC Group
n=20 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Age, Continuous
|
59.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=5 Participants
|
|
ECOG-PS
0
|
12 participants
n=5 Participants
|
|
ECOG-PS
1
|
7 participants
n=5 Participants
|
|
ECOG-PS
2
|
1 participants
n=5 Participants
|
|
Duration since diagnosis
|
9.2 months
n=5 Participants
|
|
Period of prior chemotherapy
|
5.2 months
n=5 Participants
|
|
Site of metastasis
Liver
|
9 participants
n=5 Participants
|
|
Site of metastasis
Lung
|
6 participants
n=5 Participants
|
|
Site of metastasis
Lymph node
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 2 months from the baseline, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Disease Control Rate
|
25 percentage of participants
Interval 3.78 to 46.22
|
PRIMARY outcome
Timeframe: Every 2 months from the baseline, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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.
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Stable Disease(SD)
|
4 number of participants
|
PRIMARY outcome
Timeframe: Every 2 months from the baseline, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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.
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Progressive Disease(PD)
|
12 number of participants
|
SECONDARY outcome
Timeframe: Every visit, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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).
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Overall Survival (OS)
|
26.6 weeks
Interval 8.6 to 44.6
|
SECONDARY outcome
Timeframe: Every 2 months from the baseline, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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.
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Time to Progression
|
11 weeks
Interval 8.8 to 13.2
|
SECONDARY outcome
Timeframe: Every one month from the baseline, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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.
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Global health status at baseline
|
53.65 units on a scale
Standard Deviation 29.81 • Interval 0.76 to 5.62
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Global health status at last visit
|
40.63 units on a scale
Standard Deviation 25.98
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Physical functioning at baseline
|
73.75 units on a scale
Standard Deviation 30.64
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Physical functioning at last visit
|
69.58 units on a scale
Standard Deviation 21.63
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Role functioning at baseline
|
76.04 units on a scale
Standard Deviation 32.76
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Role functioning at last visit
|
59.38 units on a scale
Standard Deviation 29.79
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Emotional functioning at baseline
|
70.31 units on a scale
Standard Deviation 20.41
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Emotional functioning at last visit
|
61.98 units on a scale
Standard Deviation 23.56
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Cognitive functioning at baseline
|
71.88 units on a scale
Standard Deviation 24.13
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Cognitive functioning at last visit
|
68.75 units on a scale
Standard Deviation 28.46
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Social functioning at baseline
|
68.75 units on a scale
Standard Deviation 20.97
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Social functioning at last visit
|
55.21 units on a scale
Standard Deviation 27.02
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Fatigue at baseline
|
40.97 units on a scale
Standard Deviation 24.59
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Fatigue at last visit
|
50.69 units on a scale
Standard Deviation 29.25
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Nausea/vomiting at baseline
|
15.63 units on a scale
Standard Deviation 25.44
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Nausea/vomiting at last visit
|
16.67 units on a scale
Standard Deviation 18.26
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Pain at baseline
|
20.83 units on a scale
Standard Deviation 25.46
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Pain at last visit
|
45.83 units on a scale
Standard Deviation 26.87
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Dyspnea at baseline
|
10.42 units on a scale
Standard Deviation 20.07
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Dyspnea at last visit
|
27.08 units on a scale
Standard Deviation 32.70
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Constipation at baseline
|
16.67 units on a scale
Standard Deviation 24.34
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Constipation at last visit
|
29.17 units on a scale
Standard Deviation 40.14
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Diarrhea at baseline
|
8.33 units on a scale
Standard Deviation 25.82
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Diarrhea at last visit
|
8.33 units on a scale
Standard Deviation 19.25
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Insomnia at baseline
|
14.58 units on a scale
Standard Deviation 20.97
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Insomnia at last visit
|
43.75 units on a scale
Standard Deviation 33.82
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Appetite loss at baseline
|
31.25 units on a scale
Standard Deviation 33.26
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Appetite loss at last visit
|
43.75 units on a scale
Standard Deviation 37.94
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Financial difficulties at baseline
|
27.08 units on a scale
Standard Deviation 30.35
|
|
Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)
Financial difficulties at last visit
|
31.25 units on a scale
Standard Deviation 33.26
|
SECONDARY outcome
Timeframe: Every one month from the baseline, up to 16 weeksPopulation: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
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.
Outcome measures
| Measure |
Immuncell-LC Group
n=16 Participants
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Pancreatic pain at baseline
|
77.08 units on a scale
Standard Deviation 23.07
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Pancreatic pain at last visit
|
60.42 units on a scale
Standard Deviation 25.91
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Gastrointestinal at baseline
|
78.13 units on a scale
Standard Deviation 29.01
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Gastrointestinal at last visit
|
63.54 units on a scale
Standard Deviation 29.32
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Jaundice at baseline
|
93.75 units on a scale
Standard Deviation 11.98
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Jaundice at last visit
|
87.50 units on a scale
Standard Deviation 16.67
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Body image at baseline
|
56.25 units on a scale
Standard Deviation 38.91
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Body image at last visit
|
56.25 units on a scale
Standard Deviation 29.74
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Altered bowel habit at baseline
|
79.17 units on a scale
Standard Deviation 24.72
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Altered bowel habit at last visit
|
61.46 units on a scale
Standard Deviation 24.13
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Health satisfaction at baseline
|
35.42 units on a scale
Standard Deviation 24.25
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Health satisfaction at last visit
|
34.38 units on a scale
Standard Deviation 27.53
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Sexuality scale at baseline
|
55.21 units on a scale
Standard Deviation 39.78
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Sexuality scale at last visit
|
54.17 units on a scale
Standard Deviation 34.16
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Bloated abdomen at baseline
|
35.42 units on a scale
Standard Deviation 25.73
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Bloated abdomen at last visit
|
54.17 units on a scale
Standard Deviation 34.16
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Taste changes at baseline
|
29.17 units on a scale
Standard Deviation 29.50
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Taste changes at last visit
|
43.75 units on a scale
Standard Deviation 35.94
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Indigestion at baseline
|
27.08 units on a scale
Standard Deviation 34.89
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Indigestion at last visit
|
41.67 units on a scale
Standard Deviation 31.03
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Flatulence at baseline
|
20.83 units on a scale
Standard Deviation 23.96
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Flatulence at last visit
|
33.33 units on a scale
Standard Deviation 32.20
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Weight loss at baseline
|
22.92 units on a scale
Standard Deviation 33.82
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Weight loss at last visit
|
27.08 units on a scale
Standard Deviation 25.00
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Decreased muscle strength at baseline
|
31.25 units on a scale
Standard Deviation 30.96
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Decreased muscle strength at last visit
|
43.75 units on a scale
Standard Deviation 29.11
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Dry mouth at baseline
|
25.00 units on a scale
Standard Deviation 31.03
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Dry mouth at last visit
|
45.83 units on a scale
Standard Deviation 34.16
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Treatment side effects at baseline
|
29.17 units on a scale
Standard Deviation 36.26
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Treatment side effects at last visit
|
39.58 units on a scale
Standard Deviation 30.35
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Fear for future health at baseline
|
52.08 units on a scale
Standard Deviation 29.74
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Fear for future health at last visit
|
58.33 units on a scale
Standard Deviation 19.25
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Ability to plan ahead at baseline
|
31.25 units on a scale
Standard Deviation 33.26
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Ability to plan ahead at last visit
|
52.08 units on a scale
Standard Deviation 27.13
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Average pain at baseline
|
1.13 units on a scale
Standard Deviation 1.89
|
|
Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)
Average pain at last visit
|
3.19 units on a scale
Standard Deviation 2.43
|
Adverse Events
Immuncell-LC Group
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immuncell-LC Group
n=20 participants at risk
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 2 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Ascite
|
5.0%
1/20 • Number of events 1 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Haematemesis
|
5.0%
1/20 • Number of events 1 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20 • Number of events 1 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
5.0%
1/20 • Number of events 1 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
General disorders
Death
|
5.0%
1/20 • Number of events 1 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
General disorders
General physical health deterioration
|
5.0%
1/20 • Number of events 1 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
Other adverse events
| Measure |
Immuncell-LC Group
n=20 participants at risk
Activated T lymphocyte, intravenous dripping of 200ml (10\^9\~2\*10\^10 lymphocytes / 60kg adult) for 1 hour.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • Number of events 9 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Number of events 7 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
5/20 • Number of events 7 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
5/20 • Number of events 6 • 1 year
Adverse events were recorded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place