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This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Adebrelimab in combination with SHR-A1811 and chemotherapy | Experimental |
| |
| Cohort B - Adebrelimab in combination with SHR-A1904 | Experimental |
| |
| Cohort D - Adebrelimab in combination with SHR-8068 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab Injection | Drug | Adebrelimab injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rate assessed by the Pathology Review Committee (PRC). | Approximately 13 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) evaluated per NCI-CTCAE v5.0. | Approximately 1 year. | |
| Incidence and severity of serious adverse events (SAEs) evaluated per NCI-CTCAE v5.0. | Approximately 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Bai | Contact | +86-0518-82342973 | bin.bai@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050010 | China |
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| SHR-A1811 for Injection | Drug | SHR-A1811 for injection. |
|
| SHR-A1904 for Injection | Drug | SHR-A1904 for injection. |
|
| SHR-8068 Injection | Drug | SHR-8068 injection. |
|
| Major pathological response (MPR) rate assessed by the Pathology Review Committee (PRC). | Approximately 13 weeks. |
| Pathological complete response (pCR) rate evaluated by the investigational site's pathology assessment. | Approximately 13 weeks. |
| Event-Free Survival (EFS). | Approximately 1 year. |
| Disease-Free Survival (DFS). | Approximately 1 year. |
| Objective Response Rate (ORR). | Approximately 1 year. |
| Overall Survival (OS). | Approximately 2 years. |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| 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 |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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