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The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A/B | Experimental | A:SHR-A2102+Adebrelimab B:SHR-A2102+Adebrelimab+Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102;Adebrelimab;Cisplatin | Drug | Drug: SHR-A2102 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks. Drug: Cisplatin Administration by intravenous infusion for a cycle of 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| RP2D | RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages; | through phase IB completion, an average of 1 years |
| Incidence and severity of AE(DLT): | According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose; | from Day1 to 90 days after last dose |
| ORR: | efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1 | 18 months after the last subject was enrolled in the group |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1; | 18 months after the last subject was enrolled in the group |
| DOR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zongyan Xie | Contact | 0518-82342973 | zongyan.xie.zx3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250117 | China |
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Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;
| 18 months after the last subject was enrolled in the group |
| PFS(Investigator evaluation) | Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1; | 18 months after the last subject was enrolled in the group |
| OS(Investigator evaluation) | Since C1D1 and death from any cause; | 18 months after the last subject was enrolled in the group |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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