Esophageal squamous cell carcinomas
Conditions
Interventions
One-armed clinical trial:combine with S-1
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients are diagnosed via histology or cytology with advanced metastatic esophageal squamous carcinoma which have one measurable lesions at least; 2. The patients have recieved at least one chemotherapy containing platinum or paclitaxel and they couldn't be tolerable or they are invalid recurrence; 3. Aged 18 - 75 years old; 4. ECOG PS 0-2; 5. The expected lifetime of patients should be equal to or more than 3 months; 6. It's four weeks or more from the last cytotoxic drugs, radiation therapy, or surgery; 7. The main organ function of patients must be normal, and should meet the following criteria (1)Blood routine examination must meet (1) HB=90 g/L (no blood transfusion within 28 days); (2) ANC=1.5×10^9/L; (3) PLT =80×10^9/L; 8. Biochemical examination should meet the following criteria: (1) ALT and AST<2.5 ULN (If patients have liver metastasis, ALT and AST<5ULN); (2) TBIL=1.5ULN; (3) SCr=1.5ULN or CCr=60ml/min; (4) The evaluation of doppler ultrasound: left ventricular ejection fraction (LVEF)=50% 9. Patient is willing to join in this study and cooperate with the follow-up, signed informed consent, with good adherence; 10. Women of child-bearing age are agreed to use contraception to avoid pregnancy during the whole period of observation and within 6 months after the last dose(e.g.The intrauterine device, the pill or condoms). The patient must recieve pregnancy test (Serum or urine) within 7 days before enrollment,and the results should be negative,and must be non lactating patients; As for men,they should agree to avoid pregnancy with appropriate method during the period of observation and within 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients have used anti-tumor angiogenesis drug, then failed; 2. There are many factors which will influence the taking and absorption of the drug (unable to swallow, chronic diarrhea and intestinal obstruction, etc.); 3. Accompanied with brain metastases symptoms or control the symptoms less than 3 months; 4. The wound and fracture have not been cured for a long time; 5. With a high risk of gastrointestinal bleeding (e.g., active peptic ulcer lesions, defecate occult blood(++), history of gastrointestinal bleeding within 6 months; abnormal Blood coagulation function (PT>16 sAPTT>43 sTT>21 sFbg 150 mmHg / diastolic blood pressure> 100 mmHg)more than primary myocardial ischemia and myocardial infarction, arrhythmia( including QTc interval>440ms)and primary cardiac insufficiency can't be admitted into the study; (2) Active or uncontrolled severe infection; (3) Liver disease such as cirrhosis of the liver, decompensated liver disease, chronic active hepatitis; (4) uncontrolled diabetes (FBG>10mmol/L); (5) Routine urine demonstrate that urinary protein>++ and confirmes that the 24 hours urinary protein quantitative>1.0g. 13. The other situation that doctor considered not suitable for enrolling in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rates;Objective response rate;quality of life;Safety indicators; | — |
Countries
China
Contacts
Public ContactCao Guochun
Jiangsu Cancer Hospital
Outcome results
None listed