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

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02504229
• Other study ID #: GC-A-004
• Status: Recruiting
• Phase: Phase 2
• First received: July 20, 2015
• Last updated: July 20, 2015
• Start date: November 2014

Study information

• Verified date: July 2015
• Source: Beijing Biohealthcare Biotechnology Co.,Ltd
• Contact: Jingwei liu, PhD
• Phone: 13241238766
• Email: ljwgirl361[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age>18y;

2. ECOG physical status 0-1;

3. The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;

4. According to the RECIST 1.1 standard with measurable or evaluable lesion;

5. Accept swallow oral drug;

6. 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;

7. The expected survival time of more than 3 months;

8. good compliance;

9. Provide written informed consent.

Exclusion Criteria:

1. Vital organs (heart,liver,kidney) function is serious dysfunction;

2. Patients received organ transplantation;

3. Patients with other malignant tumors or have occurred brain metastasis;

4. Patients with history of autoimmune disease;

5. Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);

6. Patients with acute infection disease or in chronic active stage;

7. Patients with clear history of drug allergy or belong to allergic constitution;

8. Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;

9. Patients received other clinical trials in 4 weeks.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

Biological:
• autologous dendritic cells co-cultured with cytokine-induced killer cells

Drug:
• Gimeracil and Oteracil Porassium Capsules

• Oxaliplatin

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Tumor Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Biohealthcare Biotechnology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		6 weeks	Yes