Pancreatic Cancer
Conditions
Keywords
advanced pancreatic cancer
Brief 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
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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration.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.
Interventions
BIOLOGICALActivated T lymphocyte
Intravenous dripping of 200 ml (109\ 2 1010 lymphocytes/60 kg adult) for 1 hour.
Sponsors
GC Cell Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patient aged 18 to 75 3. Patient with pathologically-confirmed, advanced pancreatic cancer 4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score) 5. Patient with anticipated survival period of more than 3 months 6. Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy 7. Patient whose blood test, renal function test and liver function test results meet the following conditions.
Exclusion criteria
1. 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.) 2. Confirmed immunodeficient patient 3. 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 4. Patient who has received systemic anti-angiogenic agent 5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy 6. Obvious myocardial failure or uncontrolled arterial hypertension 7. Patient who has experienced serious allergy (judged by the investigator) 8. Patient with serious psychological disease (judged by the investigator) 9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period 10. Patient who has participated in another clinical trial within the last 4 weeks of the start of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | Every 2 months from the baseline, up to 16 weeks | 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 |
| Stable Disease(SD) | Every 2 months from the baseline, up to 16 weeks | 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. |
| Progressive Disease(PD) | Every 2 months from the baseline, up to 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Every visit, up to 16 weeks | 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). |
| Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire) | Every one month from the baseline, up to 16 weeks | 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 to Progression | Every 2 months from the baseline, up to 16 weeks | 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. |
| Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30) | Every one month from the baseline, up to 16 weeks | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Immuncell-LC Group Activated T lymphocyte, intravenous dripping of 200ml (10\^9\
2\*10\^10 lymphocytes / 60kg adult) for 1 hour. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Immuncell-LC Group |
|---|---|
| Age, Continuous | 59.2 years |
| Duration since diagnosis | 9.2 months |
| ECOG-PS 0 | 12 participants |
| ECOG-PS 1 | 7 participants |
| ECOG-PS 2 | 1 participants |
| Period of prior chemotherapy | 5.2 months |
| Region of Enrollment Korea, Republic of | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
| Site of metastasis Liver | 9 participants |
| Site of metastasis Lung | 6 participants |
| Site of metastasis Lymph node | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 7 / 20 |
Outcome results
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
Time frame: Every 2 months from the baseline, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immuncell-LC Group | Disease Control Rate | 25 percentage of participants |
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.
Time frame: Every 2 months from the baseline, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immuncell-LC Group | Progressive Disease(PD) | 12 number of participants |
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.
Time frame: Every 2 months from the baseline, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immuncell-LC Group | Stable Disease(SD) | 4 number of participants |
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).
Time frame: Every visit, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuncell-LC Group | Overall Survival (OS) | 26.6 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.
Time frame: Every one month from the baseline, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 29.5 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 32.2 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
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.
Time frame: Every one month from the baseline, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 32.7 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
| Immuncell-LC Group | 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 |
p-value: 0.123t-test, 2 sided
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.
Time frame: Every 2 months from the baseline, up to 16 weeks
Population: Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immuncell-LC Group | Time to Progression | 11 weeks |