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The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal squamous cell carcinoma.
This is a prospective, multicenter, single-arm, phase Ⅱ clinical study to evaluate the efficacy and safety of radiotherapy alone followed by sequential injection of Toripalimab in elderly patients with unresectable esophageal squamous cell carcinoma who could not accept concurrent chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy Sequential Toripalimab | Experimental | Radiotherapy:Intensity-modulated radiotherapy (IMRT) Immunotherapy: Toripalimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | We aim to evaluate the progression-free survival (PFS) of elderly patients with unresectable esophageal squamous cell carcinoma who were unable to accept concurrent chemotherapy and received sequential treatment with Triptolide injection after radiotherapy alone. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence . | 2 years |
| Objective response rate (ORR) | Objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifeng Tian, M.D | Contact | 0578-2285350 | tzf419@hotmail.com | |
| Wencai Li, M.D | Contact | 0578-2285250 | liwencai2021@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhifeng Tian, M.D | Lishui Municipal Central Hospital,Zhejiang,China | Principal Investigator |
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participant number,age,gender
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| C000656314 | toripalimab |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D056747 | Immunomodulation |
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|
| Toripalimab | Drug | Toripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision |
|
|
| 2 years |
| Duration of response (DOR) | Duration of response (DOR) was determined from date of initial response to PD according to RECIST v1.1. | 2 years |
| Time to death or distant metastasis (TTDM) | Time to death or distant metastasis (TTDM) according to RECIST v1.1. | 2 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D001691 |
| Biological Therapy |