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Phase II clinical study of S-1 and oxaliplatin adjuvant chemotherapy combined with immunotherapy (DC plus CIK) in Locally advanced unresectable or metastatic gastric cancer

Phase II clinical study of S-1 and oxaliplatin adjuvant chemotherapy combined with immunotherapy (DC plus CIK) in Locally advanced unresectable or metastatic gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15005923
Enrollment
Unknown
Registered
2015-01-26
Start date
2015-02-11
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Sponsors

Chinese Academy of Medical Sciences Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and more; 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 lesions; 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

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.

Design outcomes

Primary

MeasureTime frame
Progression free survival;overall survival;median survival time;

Secondary

MeasureTime frame
The disease control rate;Objective remission rate;molecular markers in serum;subsets of lymphocytes in PBMC;regulator T cell in PBMC;suppressor T cell in PBMC;

Countries

China

Contacts

Public ContactWang Jin-wan\Yang Lin

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

lyang69@sina.com+86 10 87788118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026