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The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant immunotherapy-chemoradiotherapy | Experimental | This is a one arm study, enrolled locally advanced EGJ patients will receive Sintilimab (PD-1 inhibitor) and combined with preoperative chemoradiotherapy and operation. generic name：PD-1; dosage form：Injection; dosage：200mg (20ml)； frequency：every 3 weeks； duration：3 times before operation and 3-5 times after operation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1inhibitor | Drug | Patients receive 3 cycles of preoperative chemotherapy with Sintilimab（PD-1 inbibitor） and SOX (every 3 weeks), followed by radiotherapy (total dose of 36-40Gy in 18-22 fractions) during cycle 1 of the combination. Radical surgery for gastric cancer will be performed within 4-6 weeks after completion of neoadjuvant treatment, followed by 3-5 cycles of postoperative adjuvant chemotherapy with the SOX regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes | 10 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The Objective response rate (ORR) is defined as the proportion of patients with a complete response (CR) or a partial response (PR) to preoperative therapy. The ORR will be evaluated using the RESIST1.1 protocol. | 6 months after the recruitment of the last subject. |
| Disease-Free-Survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Min Jin | Recruiting | Wuhan | Hubei | 430030 | China |
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|
The time between the beginning of treatment and the observation of disease progression or death from any cause. |
| Through study completion, an average of 1 year |
| Number of participants with AEs (Adverse Events) | The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on. The AEs will be evaluated using the CTCAE 5.0 protocol. | Through study completion, an average of 1 year |
| Major pathologic response (MPR) | defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy | 10 days after operation |
| Overall survival (OS) | OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death. | Through study completion, an average of 1 year |