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DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

autologous dendritic cells co-cultured with cytokine-induced killer cells

Gimeracil and Oteracil Porassium Capsules

Oxaliplatin

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age>18y;
ECOG physical status 0-1;
The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
According to the RECIST 1.1 standard with measurable or evaluable lesion;
Accept swallow oral drug;
WBC≧4.0×10^9/L;ALC≧0.8×10^9/L;ANC≧1.5×10^9/L;PLT≧100×10^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L;
The expected survival time of more than 3 months;
good compliance;
Provide written informed consent.

Exclusion Criteria:

Vital organs (heart,liver,kidney) function is serious dysfunction;
Patients received organ transplantation;
Patients with other malignant tumors or have occurred brain metastasis;
Patients with history of autoimmune disease;
Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
Patients with acute infection disease or in chronic active stage;
Patients with clear history of drug allergy or belong to allergic constitution;
Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;
Patients received other clinical trials in 4 weeks.

Sites / Locations

Chinese Academy of Medical Sciences Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemotherapy+DC-CIK

Chemotherapy alone

Arm Description

Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles.

Chemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT02504229

First Posted

July 20, 2015

Last Updated

July 20, 2015

Sponsor

Beijing Biohealthcare Biotechnology Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02504229

Brief Title

DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Biohealthcare Biotechnology Co.,Ltd

4. Oversight

5. Study Description

Brief Summary

This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy+DC-CIK

Arm Type

Experimental

Arm Description

Arm Title

Chemotherapy alone

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

autologous dendritic cells co-cultured with cytokine-induced killer cells

Intervention Type

Drug

Intervention Name(s)

Gimeracil and Oteracil Porassium Capsules

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age>18y; ECOG physical status 0-1; The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma; According to the RECIST 1.1 standard with measurable or evaluable lesion; Accept swallow oral drug; WBC≧4.0×10^9/L;ALC≧0.8×10^9/L;ANC≧1.5×10^9/L;PLT≧100×10^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L; The expected survival time of more than 3 months; good compliance; Provide written informed consent. Exclusion Criteria: Vital organs (heart,liver,kidney) function is serious dysfunction; Patients received organ transplantation; Patients with other malignant tumors or have occurred brain metastasis; Patients with history of autoimmune disease; Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test); Patients with acute infection disease or in chronic active stage; Patients with clear history of drug allergy or belong to allergic constitution; Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks; Patients received other clinical trials in 4 weeks.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingwei liu, PhD

Phone

13241238766

ljwgirl361@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tsai Ting Huang

Phone

18610571563

huangct@biohealthcare.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jinwan Wang

Organizational Affiliation

Chinese Academy of Medical Sciences Tumor Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

lin yang

Organizational Affiliation

Chinese Academy of Medical Sciences Tumor Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese Academy of Medical Sciences Tumor Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jinwan Wang

lyang69@sina.com

First Name & Middle Initial & Last Name & Degree

lin Yang

lyang69@sina.com

First Name & Middle Initial & Last Name & Degree

jinwan Wang

First Name & Middle Initial & Last Name & Degree

lin Yang

12. IPD Sharing Statement

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