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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with Esophageal Squamous Cell Carcinoma (ESCC). Primary Efficacy Endpoint: Disease Free Survival (DFS) (According to RECIST Version 1.1), Secondary Efficacy Endpoints:1-year DFS rate, 3-year DFS rate, 1-year Overall Survival (OS) rate, 3-year OS rate, and Safety. Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Patients in the study group will receive the following treatment: 21 days as a treatment cycle, Anlotinib 12 mg/day, Orally (D1-D14); TQB 2450 1200 mg, iv (D1). If anlotinib is not tolerated, the dose can be reduced to 10mg or 8mg, until un-tolerable toxicity again. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride | Drug | Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease Free Survival | DFS was defined as the time from the day patients received first dose of treatment regimen until the date of first documented recurrence or death from any cause, whichever come first, assessed up to 96 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year DFS rate | One year Disease Free Survival rate | 1-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for one year. |
| 3-year DFS rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changying Guo, PhD | Contact | 0086-079188313179 | guochangying0809@163.com | |
| Weimin Mao, PhD | Contact | maowm1318@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Changying Guo, PhD | Jiangxi Provincial Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | China |
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| TQB2450 | Drug | TQB2450 is an injection in the form of 600 mg; 1200 mg, iv, D1. |
|
Three year Disease Free Survival rate
| 3-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for 3 years. |
| 1-year OS rate | One year Overall Survival rate | 1-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for one year. |
| 3-year OS rate | Three year Overall Survival rate | 3-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for 3 years. |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004938 | Esophageal Neoplasms |
| D004935 | Esophageal Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D009371 | Neoplasms by Site |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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