Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.
Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib 500mg qd p.o. | Experimental | Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy |
|
| Apatinib 750mg qd p.o. | Experimental | Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib 500mg qd p.o. |
| |
| Apatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | An expected average of 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Age: 18 to75 years old;
Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
Failed in first-line chemotherapy or radiotherapy treatment;
ECOG PS of 0-1;
An expected survival of ≥ 3 months;
No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored;
Major organ function has to meet the following criteria:
ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST<2 × ULN; Plasma Cr<1.5 × ULN
Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
Researchers believe that patients can benefit;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen xiaofei, MD | Contact | +86-13915107001 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huaian First People's Hospital | Recruiting | Huaian | Jiangsu | China |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C553458 | apatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Apatinib 750mg qd p.o. |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |