Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic cancer.

Official Title
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Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: DC-CIK Treatment
* Drug: S1
* Other: Best supportive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery. Capable of oral intake Between 18 and 80 years old Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Karnofsky Performance Status (KPS) ≥ 70% Normal functions of heart, lung and bone marrow Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3 Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN Adequate renal function(normal serum creatinine level) A life expectancy≥ 2 months Informed consent signed Exclusion Criteria: Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study Any radiotherapy or surgery within the previous 3 weeks Symptomatic brain metastasis not controlled by corticosteroids Bone marrow metastasis Active infection Serious complications Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 plus DC-CIK<br>Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks. DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles. | Biological: DC-CIK Treatment<br>* The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.<br>Drug: S1<br>* The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25-<1.5 m2, 50 mg; and >1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.<br>|
| Active Comparator: DC-CIK alone<br>DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles. | Biological: DC-CIK Treatment<br>* The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.<br>|
| Active Comparator: S-1 alone<br>Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks. | Drug: S1<br>* The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25-<1.5 m2, 50 mg; and >1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.<br>|
| Active Comparator: Best supportive care<br> | Other: Best supportive care<br>* Best supportive care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment toxicity | Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The disease control rate | the proportion of patients who had a best response rating of complete response, partial response, or stable disease. | 4 years | 
| Progression free survival（PFS） | From starting date of enrollment to this study until date of first documented disease progression or date of death from any cause, whichever comes first. | 4 years | 
| Overal survival(OS) | From starting date of enrollment to this study until date of death from any cause | 4 years | 
| Changing trend of tumor biomarkers | The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy | 4 years | 
| Phenotypic analysis of peripheral blood immune cells | Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S1, Pancreatic Cancer, DC-CIK