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This is a single-arm, exploratory clinical study to evaluate the efficacy and safety of Preoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen in resectable locally advanced gastric/gastroesophageal junction adenocarcinoma.
All eligible subjects will receive 5*5Gy (25Gy/5F) fractionated radiotherapy, rest for 1 week, 3 cycles of Envafolimab, Endostatin and SOX regimen, and radical surgery 2 to 4 weeks after completion of the last neoadjuvant therapy, according to the study plan. Each patient will be followed up 12 months after initiation of treatment in the study. Whether the subjects need adjuvant therapy after surgery and the adjuvant treatment plan are determined by the investigator. All subjects were required to complete the study follow-up plan after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envafolimab, Endostatin and SOX regimen | Experimental | Preoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab | Drug | short course radiotherapy :5*5Gy (25Gy/5F) ; Envafolimab:300 mg, subcutaneously, D1, Q3W; Endostatin :210mg (14 doses), CIV continuously pumped for 72h, Q3W; chemotherapy:SOX regimen |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | Pathological complete response (pCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rates | R0 resection was performed if there was no visible tumor residue within 1 mm of the surgical margin. | one year |
| pathological partial response(MPR) | It was defined as ≤ 10% remaining viable tumor cells at surgical resection of the primary tumor |
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Inclusion Criteria:
1. Signed written informed consent before enrollment; 2.18 years old ≤75 years old, male or female; 3. Initially diagnosed locally advanced gastric/gastroesophageal junction adenocarcinoma confirmed by tissue or pathology; 4. Without systemic treatment; 5. Patients diagnosed as CT2-4an + M0 according to endoscopic ultrasonography or enhanced CT/MRI scan cTNM were assessed by researchers as suitable for neoadjuvant therapy + radical surgery. AJCC/UICC Version 8 was used for TNM pathological staging (pTNM).
6.ECOG PS score: 0 ~ 1; 7. The expected survival time is more than 6 months; 8. The function of vital organs meets the following requirements (excluding any blood components and cell growth factors within 14 days) :
Blood routine:
Neutrophils ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin ≥ 90g/L;
Liver and kidney function:
Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥50 mL /min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times normal upper limit (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal value (ULN) (≤5ULN if abnormal liver function is due to liver metastasis); Urine protein & lt; 2 +; If urine protein ≥2+, 24-hour urine protein quantification must be ≤1g; 9. Normal coagulation function, no active bleeding and thrombotic diseases
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dan dan Yu | Contact | 027-85871982 | yudandan@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tao Zhang, MD | Cancer Center, Union Hospital, Tongji Medical College | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34154614 | Result | Li J, Deng Y, Zhang W, Zhou AP, Guo W, Yang J, Yuan Y, Zhu L, Qin S, Xiang S, Lu H, Gong J, Xu T, Liu D, Shen L. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021 Jun 21;14(1):95. doi: 10.1186/s13045-021-01095-1. |
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|
| one year |
| ID | Term |
|---|---|
| C000718749 | envafolimab |
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
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