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The purpose of this study is to assess efficacy and safety of patients who receive camrelizumab as consolidation therapy after radical concurrent chemoradiotherapy in locally advanced ESCC.
In this study, 40 patients with locally advanced ESCC will be enrolled. All patients who had received radical concurrent chemoradiotherapy were treated with camrelizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab | Experimental | All patients who had received radical concurrent chemoradiotherapy were treated with camrelizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab: 200 mg was given intravenously over a period of 30 minutes (no less than 20 minutes and no longer than 60 minutes) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Durarion of response (DOR) | From the first assessment to CR or PR to the first assessment to PD or death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Relationship between tumor markers and efficacy in tumor tissues and peripheral blood (including but not limited to PD-L1, TMB, etc.) | up to 24 months |
Inclusion Criteria:
1)For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥80×109/L; 2)For results of blood biochemical test ALB≥30g/L; ALT and AST<2.5×ULN; TBIL≤1.5ULN; Serum creatinine ≤1.5ULN; 9. Left ventricular ejection fraction (LVEF) ≥50%; 10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria:
6.Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or Unexplained fever>38.5℃ during screening visits or on the first scheduled day of dosing; 7.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8.Less than 4 weeks from the last clinical trial; 9.History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10.The researchers think inappropriate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JUN WANG, Ph.D | Contact | 13931182128 | wangjunzr@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 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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| tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Overall survival (OS) | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to 24 months |
| Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit | up to 24 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |