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

Study Overview
=================
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 To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration.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.

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

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Biological: Activated T lymphocyte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immuncell-LC group<br>Intravenous dripping of 200 ml (109 2 1010 lymphocytes/60 kg adult) for 1 hour. | Biological: Activated T lymphocyte<br>* Intravenous dripping of 200 ml (109 2 1010 lymphocytes/60 kg adult) for 1 hour.<br>* Other names: Immuncell-LC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced pancreatic cancer