Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer

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

Official Title
-----------------
Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Biological: DC-CIK
* Drug: S-1
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma Between 18 and 80 years old Capable of oral intake 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 4 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 Ineligible for the study at the discretion of investigators

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

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: DC-CIK plus S-1 based chemotherapy<br>Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent. | Biological: DC-CIK<br>* Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.<br>Drug: S-1<br>* The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.<br>Drug: Cisplatin<br>* Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.<br>|
| Active Comparator: S-1 based chemotherapy<br>Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent. | Drug: S-1<br>* The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.<br>Drug: Cisplatin<br>* Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival（PFS） |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 4 years | 
| Response rate |  | Every 6 weeks | 
| Adverse Events |  | Every 3 weeks | 
| Quality of life | Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, S-1, DC-CIK, T cell