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The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib(500mg/d)for the second - line treatment of esophageal cancer or esophageal and gastric
This study is a prospective,single-center,single arm,â…¡ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The main research object for first-line treatment failure â…¢/â…£ integration of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary research is to evaluate the safety of apatinib for second-line treatment of esophageal and esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and explore the relationship between VEGFR-2 high expression and apatinib efficacy and related prognostic factors. Thirty patients were enrolled in the study group. The group was expected to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the CRF table for details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Apatinib:500 mg,po,qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Targeted therapy Apatinib:500 mg,po,qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate(ORR):The proportion of patients who have been reduced to a certain amount and maintained a certain amount of time, including the CR + PR case. | Through study completion, an average of 0.5 year |
| median Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pan Zhanyu, Master | Contact | 86-13752570372 | liyanwei127@hotmail.com | |
| LI Yanwei, Master | Contact | 86-13920292059 | liyanwei127@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pan Zhanyu, Master | 86-13752570372 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
PFS data of patients in this trial are expected to be Shared
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median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason. |
| Through study completion, an average of 1.5 year |
| 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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| ID | Term |
|---|---|
| C553458 | apatinib |
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