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This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 250 mg PO qd. |
|
| B | Active Comparator | Capecitabine 1000 mg/m^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus Oxaliplatin 130 mg/m^2, IV q3w |
|
| C | Experimental | Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m^2, IV q3w; for 4-6 cycles followed by SHR-1210 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of SHR-1210 in combination with capecitabine + oxaliplatin sequenced by SHR-1210+apatinib versus capecitabine + oxaliplatin in all subjects or programmed cell death ligand 1 (PD-L1) positive participants | Up to 36 months after the first participant is randomized. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to approximately 36 months. | |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to approximately 36 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital, Peking University | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41819560 | Derived | Peng Z, Zhang Y, Xu H, Yang Y, Yang M, Zhang M, Cheng Y, Chen X, Pan Y, Wang F, Li Q, Xu N, Liu L, Gu K, Xiao J, Zhang R, Zhao Q, Chen J, Lin L, Chen Y, Deng Y, Cai S, Bai B, Wang Y, Shen L. Camrelizumab plus CAPOX with camrelizumab based maintenance versus CAPOX alone as initial treatment for gastric or gastro-oesophageal junction adenocarcinoma: randomised phase 3 trial. BMJ. 2026 Mar 12;392:e086115. doi: 10.1136/bmj-2025-086115. |
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| Capecitabine | Drug | 1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle. |
|
| Oxaliplatin | Drug | 130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle. |
|
| Apatinib | Drug | 250 mg administered as continuous oral once daily (QD) of each 3-week cycle. |
|
| Incidence and severity of adverse events (AEs) | Up to approximately 36 months. |
| Incidence and severity of serious adverse events (SAEs) | Up to approximately 36 months. |
| Overall survival (OS) rates at 12 months, 18 months and 24 months | Up to approximately 12 months, 18 months and 24 months. |
| Progression-free Survival (PFS) rates at 6 months | Up to approximately 6 months. |
| Disease Control Rate (DCR) per RECIST 1.1 | Up to approximately 36 months. |
| Duration of Response (DoR) per RECIST 1.1 | Up to approximately 36 months. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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