Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01783951 |
Recruitment Status :
Completed
First Posted : February 5, 2013
Last Update Posted : July 19, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Biological: DC-CIK Drug: S-1 Drug: Cisplatin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | February 1, 2013 |
Actual Primary Completion Date : | February 2018 |
Actual Study Completion Date : | June 1, 2018 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783951
China, Beijing | |
Capital Medical University Cancer Center | |
Beijing, Beijing, China, 100038 |
Responsible Party: | Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center, Capital Medical University |
ClinicalTrials.gov Identifier: | NCT01783951 |
Other Study ID Numbers: |
S1+DC CIK- G |
First Posted: | February 5, 2013 Key Record Dates |
Last Update Posted: | July 19, 2018 |
Last Verified: | July 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastric cancer S-1 DC-CIK T cell |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Cisplatin Antineoplastic Agents |