Malignant tumors of the esophagus/esophagogastric junction
Conditions
Interventions
treatment group:Anlotinib + nedaplatin + capecitabine
control group:Nedaplatin + capecitabine
Sponsors
The Second Hospital of Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study and sign the informed consent. They have good compliance and cooperate with follow-up; 2. Male or female, aged 18 to 70 years; 3. Histologically or cytologically confirmed squamous cell carcinoma/adenocarcinoma of the esophagus and esophagogastric junction; 4. Resectable, measurable squamous cell carcinoma/adenocarcinoma of the esophagus and esophagogastric junction as specified in 2020CSCO guidelines; 5. Life expectancy of at least 1 year; 6. ECOG score: 0-2 points; 7. Major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination must be met (no blood transfusion or blood products within 14 days, no correction by G-CSF or other hematopoietic stimulating factors) : 1) Hb >=90g/L; 2)A NC acuity 1.5 x 10^9 / L; 3)P LT 80 x 10^9 / L or higher. (2) Biochemical tests should meet the following criteria: 1) TBil 45 mL /min (Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Suffered from other malignant tumors within 5 years or at the same time; 2. Used systemic chemotherapy more than once in front-line treatment; 3. People known to be allergic to amlotinib hydrochloride capsules; 4. Previous use of other antiangiogenic drugs; 5. Complicated diseases and medical history, including: (1) Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT>1.5ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; (2) Renal insufficiency: urine routine suggested urine protein >= ++, or confirmed urine protein volume >=1.0g in 24 hours; (3) Poor blood pressure control (systolic blood pressure >=160 mmHg, diastolic blood pressure >=100 mmHg); (4) Severe acute or chronic infections requiring systemic treatment; (5) Severe cardiovascular diseases: myocardial ischemia or myocardial infarction above ?, poorly controlled arrhythmias (including QTC interval >=450 ms for male and >=470 ms for female);According to NYHA standard, ?~L cardiac dysfunction, or heart color ultrasound examination indicated left ventricular ejection fraction (LVEF) =CTC AE grade 2 dyspnea); (7) Uncontrollable serosal cavity effusion (including pleural effusion, ascites and pericardial effusion) was determined by the researcher after the treatment by pumping fluid; (8) Diabetes mellitus with poor blood glucose control (fasting blood glucose (FBG) > 10mmol/L) or other conditions with high dose of glucocorticoid therapy; (9) Long-term unhealed wounds or fractures; (10) There are significant factors affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; (11) Artery/venous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; (12) Peripheral neuropathy >= CTCAE 2 degree is present, except due to trauma; 6. Physical examination and laboratory examination (1) A known history of positive human immunodeficiency virus (HIV) tests or a known history of acquired immunodeficiency syndrome (AIDS); (2) A known history of clinically significant liver disease, including viral hepatitis, and known hepatitis B virus (HBV) carriers must be ruled out for active HBV infection, i.e. HBV DNA positive (>2500 copies /mL or >500IU/mL);Known hepatitis C virus infection (HCV) and HCV RNA positive (>1x10^3 copies /mL), or other decompensated liver disease, chronic hepatitis should be treated with antiviral therapy. 7. Pregnancy test (serum or urine) of women of childbearing age was positive within 7 days before enrollment.In men, they refused to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug. 8. Pregnant women; 9. Participating in other clinical studies (except non-interventional studies) or less than 4 weeks from the end of treatment in the previous clinical study; 10. Patients judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Pathological complete response;Disease control rate;progression free survival; | — |
Countries
China
Contacts
Public ContactZhao Xiaogang
The Second Hospital of Shandong University
Outcome results
None listed