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The purpose of this study is to evaluate the efficacy and safety of **Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX** as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with CAPOX | Active Comparator |
| |
| Disitamab Vedotin Combined with Tislelizumab and CAPOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine | Biological | Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 100 mg/m², IV, D1, Q3W; Capecitabine: 750 mg/m², po, BID, D1-D14, Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | up to 5 years | |
| Objective Response Rate | 24 months | |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SU Xiaohong Study Director, M.D | Contact | +0810-65391479 | xiaohong.su@remegen.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | BJ-Beijing | 100021 | China |
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| Tislelizumab+Oxaliplatin+Capecitabine | Biological | Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W |
|
| 24 months |
| Duration of Response | 24 months |
| Patient-Reported Outcomes | 24 months |
| Adverse Events | 24 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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