Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study

Conditions
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Stomach Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Stomach Diseases, Neoplasms by Site

Intervention / Treatment
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* Drug: Camrelizumab
* Drug: SOX
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 18 years of age; Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma; Without prior systematic therapy; The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1; With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS; Life expectancy longer than 12 months; Adequate function of blood, heart, liver, kidney and thyroid. Exclusion Criteria: History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; Unresectable tumor evaluated by investigator; 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; With tumors in other sites; 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; Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin; With any mental illness; Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camrelizumab+SOX<br>The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin). | Drug: Camrelizumab<br>* 200mg, intravenously, d1<br>Drug: SOX<br>* SOX (S-1: 40 60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)<br>Procedure: Surgery<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response (pCR) rate | The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR) | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate |  | 2-4 months | 
| Overall response rate(ORR) |  | 2-4 months | 
| Disease control rate(DCR) |  | 2-4 months | 
| Major pathological response (MPR) | The AJCC TRG system was used in this study to determine the effects of treatment. | 2-4 months | 
| Adverse events (AE) rate |  | 3 years | 
| Event-free survival(EFS) |  | 3 years | 
| Overall survival(OS) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, neoadjuvant chemoimmunotherapy, neoadjuvant immunotherapy