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The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unresectable locally advanced/recurrent or metastatic esophageal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of Camrelizumab | especially Occurrence of ≥Grade 3 immune-related AEs | an expected average of 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of Camrelizumab | including other occasional or rare AEs | an expected average of 24 months |
| Overall Survival | Duration from the date of initial treatment to the date of death due to any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Correlations between biomarkers and clinical activity | tumor biopsies are collected before start of treatment, for assessing the relationship between different biomarkers (e.g. PD-L1 expression) with different camrelizumab-based regimens | an expected average of 24 months |
Inclusion Criteria:
Sign informed consent and voluntarily participate in this study.
Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);
Age ≥ 18 years old;
The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.
Exclusion Criteria:
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unresectable locally advanced/recurrent or metastatic esophageal cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| an expected average of 24 months |
| Progression-free Survival (PFS) | A duration from the date of initial treatment to radiographic disease progression or death of any cause | an expected average of 24 months |
| Objective Response Rate (ORR) | Proportion of objective complete response and partial response patients | an expected average of 24 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |