a study of second-line treatment of postoperative recurrence and metastasis of esophageal cancer treated with apatinib

Conditions: Esophageal Neoplasms

Summary: a study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate

this is a randomized, open-label, multi-center, phase ii clinical trial initiated by a investigator to observe and evaluate the efficacy of apatinib in the treatment of patients with failed first-line treatment after recurrence and metastasis of esophageal squamous cell carcinoma. effectiveness and security.

Eligibility criteria:
inclusion criteria: * pathological/histological diagnosis of esophageal squamous cell carcinoma; and at least one measurable lesion according to recist criteria (version 1.1); * patients who have undergone radical resection of esophageal cancer and who have failed after first-line systemic chemotherapy (which may include platinum, taxane or fluorouracil) after recurrence (recurrence of postoperative adjuvant chemotherapy within 6 months) considered as first-line treatment, and the same progress in the field of radiation can be seen as recurrence; * age: 18-75 years old; both men and women; * ecog ps rating: 0-1 points; * estimated survival period ≥ 3 months; * ≥ 4 weeks from the last cytotoxic drug; * the main organs function normally, that is, meet the following criteria: * blood routine examination: * hb≥90 g/l; (no blood transfusion within 14 days) * anc ≥ 1.5 × 109 / l; * plt ≥ 80 × 109 / l; * biochemical examinations must meet the following criteria: * alt and ast \< 2.5 uln; if there is liver metastasis, alt and ast \< 5 uln; * tbil ≤ 1.5uln; * plasma cr≤1.5uln or creatinine clearance (ccr)≥60ml/min * subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up. * women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months of the end of the study; negative serum or urine pregnancy tests within seven days prior to study enrollment and must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period. exclusion criteria: * those who have used anti-tumor angiogenesis drugs to treat failure; * patients with residual esophagus, residual stomach or anastomotic recurrence; * unable to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the taking and absorption of drugs; * patients with brain metastases with symptoms or symptoms controlled for less than 3 months; * long-term unhealed wounds and fractures; * have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood above ++), history of gastrointestinal bleeding within 6 months; coagulation abnormalities (pt\>16 s, aptt\>43 s, tt\>21 s, fbg\< 2 g/l), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; * overactive/venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; * imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels during the follow-up study and cause fatal bleeding. * persons with a history of psychotropic substance abuse who are unable to resolve or have a mental disorder; * participated in other clinical trials of anti-tumor drugs within four weeks; * have a history of immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; * according to the investigator's judgment, there are serious concomitant illnesses that compromise the safety of the patient or affect the patient's completion of the study. * patients with any severe and/or uncontrolled diseases, including: * blood pressure control is unreasonable (retraction pressure \>150mmhg, diastolic pressure \>100mmhg) patients: i have myocardial ischemia or myocardial infarction above grade i, arrhythmia (including qt interval \>440ms) and grade i cardiac insufficiency; * active or uncontrolled serious infections; * liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; * poor diabetes control (fasting blood glucose fbg\>10mmol/l); * urine routine indicates urinary protein \>++, and confirmed 24-hour urine protein quantitation \>1.0g. * the investigator believes that it is not suitable for inclusion.