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

Capital Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gastric Cancer

Treatments: Biological: DC-CIK; Drug: Cisplatin; Drug: S-1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01783951

S1+DC CIK- G

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

DC-CIK plus S-1 based chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: S-1

Drug: Cisplatin

Biological: DC-CIK

S-1 based chemotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: S-1

Drug: Cisplatin