A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.

Official Title
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A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: camrelizumab+chemotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up; Male or female patients between the ages of 18-75; Patients diagnosed as gastric adenocarcinoma by histology or cytology; Stage: Locally advanced stage (T3-4aN1-3M0); Have not received other immunotherapy drugs or chemotherapy drugs in the past; ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; Has sufficient organ and bone marrow function Exclusion Criteria: Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)]; A distant metastasis occurs; Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.); Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea); Patients with any severe and/or uncontrollable disease； Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study; Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping; Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; People with a history of psychotropic drug abuse and unable to quit or have mental disorders; Participated in other anti-tumor drug clinical trials within four weeks; According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; Female patients who are pregnant or breastfeeding; Known hypersensitivity to any study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: camrelizumab+chemotherapy<br>neoadjuvant treatment with camrelizumab+chemotherapy | Drug: camrelizumab+chemotherapy<br>* camrelizumab 200mg，ivdrip，q3w； albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1 d14，q3w. 3 cycles.<br>|
| Active Comparator: chemotherapy<br>neoadjuvant treatment with chemotherapy | Drug: Chemotherapy<br>* albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1 d14，q3w. 3 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major pathologic response rate | complete or subtotal regression (<10% residual tumor per tumor bed) | one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete pathologic response rate | complete regression (no residual tumor per tumor bed) | one month after surgery | 
| R0 resection rate | surgically removed tissue without residual cancer cells | one month after surgery | 
| Overall survival | the time from the start of randomization to death due to any cause. | 3 years | 
| Disease-free survival | the time from the start of randomization to the incurable resection, local recurrence or metastasis, or death from any cause. | 3 years | 
| perioperative complications | perioperative complications | the time from the start of randomization to 3 months after surgery | 

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