Stomach Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Stomach Diseases, Neoplasms by Site
Conditions
Keywords
gastric cancer, neoadjuvant chemoimmunotherapy, neoadjuvant immunotherapy
Brief summary
This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.
Interventions
DRUGCamrelizumab
200mg, intravenously, d1
DRUGSOX
SOX (S-1: 40\ 60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
PROCEDURESurgery
Surgery
Sponsors
The Second Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age older than 18 years of age; 2. Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma; 3. Without prior systematic therapy; 4. The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1; 5. With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; 6. Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS; 7. Life expectancy longer than 12 months; 8. Adequate function of blood, heart, liver, kidney and thyroid.
Exclusion criteria
1. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; 2. Unresectable tumor evaluated by investigator; 3. Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention; 4. With tumors in other sites; 5. History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included; 6. Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin; 7. With any mental illness; 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pCR) rate | 2-4 months | The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) | 2-4 months | — |
| Disease control rate(DCR) | 2-4 months | — |
| Major pathological response (MPR) | 2-4 months | The AJCC TRG system was used in this study to determine the effects of treatment. |
| R0 resection rate | 2-4 months | — |
| Event-free survival(EFS) | 3 years | — |
| Overall survival(OS) | 5 years | — |
| Adverse events (AE) rate | 3 years | — |
Countries
China
Outcome results
None listed