Esophageal Cancer
Conditions
Interventions
the first cohort:Apatinib Mesylate Tablets 250 mg qd p.o.
the second cohort:Apatinib Mesylate Tablets 500 mg qd p.o.
the third cohort:Apatinib Mesylate Tablets 750 mg qd p.o.
the fourth cohort:Apatinib Mesylate Tablets 850 mg qd p.o.
Intervention Group(1-4):concurrent chemoradiation
Sponsors
Secondly Hospital, Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Histologically proven esophageal squamous cell carcinoma; 3. Patients are reluctant to surgery or can not tolerate surgery or the patient's stage are III-IVa; 4. KPS>=70, Life expectancy >=6 months; 5. Major organ function has to meet the following criteria: HB >=100g/L,ANC >=1.5*10^9/L, PLT >=100*10^9/L, Bilirubin <1.5 times the upper limit of normal (ULN), ALT and AST <1.5*ULN, Cr<=1.5*ULN; 6. No prior treatments of irradiation; 7. No prior treatments of chemotherpy within 6 months; 8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Exclusion criteria
Exclusion criteria: 1. Confirmed that apatinib and/or its accessories and 5-flouracial and cis-platinum allergy; 2. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man >450 ms, for woman >470 ms) together with Class II cardiac dysfunction; 3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 4. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months; 5. Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed; 6. Associated with CNS (central nervous system) metastases; 7. Pregnant or lactating women; 8. Pts with other malignant tumor within 5 years (except cured skin basal cell carcinoma and cervical carcinoma); 9. With psychotropic drug abuse history and can't get rid of or mental disorder patients; 10. Participated in other clinical trials within 4 weeks; 11. Pts received VEGFR inhibitor treatment (i.e. sorafenib, sunitinib); 12. Any other condition that might place the patient at undue risk or preclude a patient from completing the study; 13. Other conditions regimented at investigators' discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerance dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJin Gang
Outcome results
None listed