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This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1:SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701, apatinib, and SOX | Experimental |
| |
| SHR-1701 and SOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 | Drug | SHR-1701, 1800mg, Q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Regression Grade (TRG) | Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | |
| ypN staging | Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
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Inclusion Criteria:
Exclusion Criteria:
5. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy); 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)
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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| C553458 | apatinib |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| apatinib |
| Drug |
apatinib 250mg,Q3W |
|
| S-1 & Oxaliplatin | Drug | S-1, Oxaliplatin, Q3w |
|
| R0 resection rate | Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Event free survival (EFS) | Up to approximately 4 years |
| Disease-free survival (DFS) | Up to approximately 4 years |
| Overall survival(OS) | Up to approximately 4 years |
| AEs | Up to approximately 3 years |