esophageal cancer
Conditions
Interventions
Case series:Anlotinib combined with Gemcitabine
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years old; 2. patients with advanced esophageal cancer diagnosed by pathology and imaging; 3. patients with advanced esophageal cancer who have received systematic radiotherapy and chemotherapy; 4. no significant bleeding risk, no systemic metastasis or metastasis, the focus was controlled; 5. ECOG physical condition score 0-1 points, can withstand treatment; 6. Life expectancy is more than 3 months; 7. main organ function is good, without serious hypertension, diabetes and heart disease: (1) hemoglobin is greater than or equal to 90 g/L (no blood transfusion within 14 days); (2) Neutrophil count > 1.5x10^9 /L; (3) Platelet count greater than or equal to 100 x 10^9/L; Biochemical examination: (1) total bilirubin is less than or equal to 1.5 * ULN (upper limit of normal value); (2) ALT or AST less than or equal to 2.5 * ULN; In the case of liver metastasis, ALT or AST is less than or equal to 5 * ULN; (3) Endogenous creatinine clearance is more than 60ml/min (Cockcroft-Gault formula); Cardiac doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) is greater than 50%; Blood glucose should be controlled at fasting blood glucose <7.2mmol/L, non-fasting blood glucose <10mmol/L, and glycosylated hemoglobin <7%. 8. Signed informed consent; 9. the compliance was good and the family members agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. participated in other drug clinical trials within four weeks; 2. has a variety of factors influencing oral drugs (such as: unable to swallow, chronic diarrhea and intestinal obstruction, etc.); 3. a history of bleeding, screening occurred within 4 weeks before any serious grading achieve CTCAE4.0 3 degrees or above of bleeding events; 4. there are obvious bleeding risk, such as: (1) imaging shows that the tumor has violated important blood vessels or by the researchers to determine the tumor patients during treatment have extremely high may invade important blood vessels and cause fatal haemorrhage; (2) coagulant function abnormality, with bleeding tendency (14 days before randomization must be satisfied: In the case of without the use of anticoagulants INR within the normal range); (3) application of anticoagulant or vitamin K antagonists such as warfarin and heparin or its analogues treatment, in the standardization of the prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily); 5. before the screening of the central nervous system known to have transfer or patients with a history of the central nervous system transfer. For patients with clinical suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before treatment to exclude central nervous system metastasis. 6 should be surgical sterilization, postmenopausal women patients, or agreed to in the research during the treatment and research within 6 months after the end of the treatment period use of an approved by the medical contraception; The serum or urine pregnancy test must be negative within 7 days prior to study enrollment and must be non-lactation; All landowners had high blood pressure and the single antihypertensive drug treatment cannot get good controller (systolic blood pressure > 140 MMHG, diastolic blood pressure > 90 MMHG); Having a history of unstable angina pectoris; Patients newly diagnosed with angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmia (including QTcF: greater than 450ms for men and 470ms for women) requires long-term use of anti-arrhythmia drugs and New York heart association grade II or greater cardiac dysfunction; Always end up other serious complications: (1) abnormal thyroid function, even in the case of drug treatment, thyroid function is still unable to maintain within the normal range; (2) has a history of psychotropic substance abuse and is unable to quit or has a mental disorder; (3) pleural effusion or peritoneal effusion with clinical symptoms requiring clinical intervention; (4) have a history of immune deficiency, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; (5) urine routine test indicated that urine protein was greater than ++ and confirmed that 24-hour urine protein quantitative > 1.0g; (6) long-term unhealed wounds or incomplete fractures; (7) screening for the occurrence of hyperarteriovenous thrombosis events in the first 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep vein thrombosis (except those who have been cured due to intravenous catheterization in early chemotherapy determined by the researchers) and pulmonary embolism; (8) according to the judg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS;PFS;ORR;side effects; | — |
Countries
China
Contacts
Public ContactLiu Fang
General Hospital of Chinese People's Liberation Ar
Outcome results
None listed