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

Sponsor

Capital Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT01783951

Collaborator

Duke University (Other), Geneplus-Beijing Co. Ltd. (Industry)

Enrollment

Location

Arms

63.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Biological: DC-CIK Drug: S-1 Drug: Cisplatin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DC-CIK plus S-1 based chemotherapy 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 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. Drug: S-1 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. Drug: Cisplatin Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.
Active Comparator: S-1 based chemotherapy 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 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. Drug: Cisplatin Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

Arm

Intervention/Treatment

Experimental: DC-CIK plus S-1 based chemotherapy

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

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.

Drug: S-1

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.

Drug: Cisplatin

Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

Active Comparator: S-1 based chemotherapy

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

Drug: Cisplatin

Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.

Outcome Measures

Primary Outcome Measures

Progression free survival（PFS） [4 years]

Secondary Outcome Measures

Overall survival [4 years]
Response rate [Every 6 weeks]
Adverse Events [Every 3 weeks]
Quality of life [6 weeks]
Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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