study of anlotinib in patients with esophageal squamous cell carcinoma (alter1102)

Conditions: Esophageal Squamous Cell Carcinoma

Summary: to compare the effects and safety of anlotinib with placebo in patients with esophageal squamous cell carcinoma(escc).


Eligibility criteria:
inclusion criteria: * histological documentation of esophageal squamous cell carcinoma； * advanced esophageal squamous cell carcinoma with distant metastasis(stage iv),at least one measurable lesion (by recist1.1) * patients who at least have failed to a platinum-based chemotherapy treatment or chemotherapy containing paclitaxel. note: (1) each line treatment refers to treatment duration at least one cycle using monotherapy or drug combination; (2)adjuvant chemotherapy or neoadjuvant chemoradiation is permitted before the study (if disease recurred during adjuvant chemotherapy/neoadjuvant chemoradiation or recurred within 6 months after stopping treatment, adjuvant chemotherapy/neoadjuvant chemoradiation can be considered as first line systemic chemotherapy; * 18-75 years,ecog ps:0-2,life expectancy of more than 3 months * 4 weeks or more from the last cytotoxic therapy, radiation therapy or surgery * main organs function is normal * women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * patients whose primary lesion with active bleeding within 2 months * primary lesion not resected and has not shrinked after radiation therapy * patients who have been failure with anti-tumor angiogenesis drug treatment * patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.) * brain metastases patients with symptoms or symptoms controlled \< 3 months * patients with any severe and/or unable to control diseases，including： 1. blood pressure unable to be controlled ideally(systolic pressure≥150 mmhg，diastolic pressure≥100 mmhg); 2. patients with grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qt≥480ms) and patients with grade 1 or higher congestive heart failure (nyha classification); 3. patients with active or unable to control serious infections; 4. patients with cirrhosis, decompensated liver disease, or active hepatitis; 5. patients with poorly controlled diabetes (fasting blood glucose(fbg)\>10mmol/l) 6. urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed * patients with non-healing wounds or fractures * patients with any ctc ae grade 1 or higher bleeding events occurred in the lungs or any ctc ae grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation * patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism * patients with drug abuse history and unable to get rid of or patients with mental disorders * imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage * patients participated in other anticancer drug clinical trials within 4 weeks * history of immunodeficiency * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Keywords: anlotinib