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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 (Tegafur+Oxaliplatin) for locally advanced esophagogastric junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) Combined With Chemotherapy (Tegafur+Oxaliplatin) Each patient will complete 3 cycles of neoadjuvant therapy. After evaluating the radiographical response, operation with curative extent (Ivor-lewis or Mckeown procedure with two-field lymph node dissection) will be performed after 6 to 8 weeks from the last cycle of neoadjuvant treatment. Patients with and without surgery enter the survival follow-up period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg iv drip. Qd D1 + Oxaliplatin 130/m2 iv drip. Qd D1 + Tegafur (Gimeracil and Oteracil Potassium Capsules) [40mg/m2 if BSA <1.25m2, 50mg/m2 if BSA ≥1.25m2 & <1.5m2, 60mg/m2 if BSA ≥1.5m2] po. Bid D1-14 for three cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes | From date of enrollment until one month after resection |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from randomization to death from any cause. | 2-5 years |
| Disease-Free-Survival | The time between the beginning of treatment and the observation of disease progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Yang, M.D. Ph.D. | Contact | +8613560405144 | +8613560405144 | yanghong@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
upon reaseonable request with a plan
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| 2-5 years |
| R0 resection rate | The percentage of patients who undergo complete resection | From date of enrollment until one month after resection |