Esophageal squamous cell carcinoma
Conditions
Interventions
Experience group:Chemotherapy + androtinib
control group:Chemotherapy
Sponsors
Nanyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, gender unlimited; 2. The patients with esophageal squamous cell carcinoma were confirmed by pathology, and the local advanced stage was unresectable, local recurrence or distant metastasis; 3. Advanced esophageal squamous cell carcinoma progressed after first-line chemotherapy (platinum based, fluorouracil based, paclitaxel based chemotherapy); after first-line adjuvant radiotherapy and chemotherapy for postoperative recurrence and metastasis; within 6 months after the end of radical synchronous radiotherapy and chemotherapy, neoadjuvant / adjuvant therapy, the disease progressed or recurred; 4. According to the RECIST 1.1 standard, the patient has at least one measurable target focus (CT scan length and diameter of tumor focus >=10 mm); 5. Estimated survival time >=3 months; 6. ECoG scoring standard: 0-1; 7. Without molecular targeted drug treatment; 8. The main organs function well, that is to say, the relevant examination indexes before randomization meet the following requirements: (1) Blood routine examination: Hemoglobin >=90 g/L; Neutrophil count >=1.5x10^9/L; Platelet count >=100x10^9/L; WBC count >=3.5x10^9/L; (2) Biochemical examination: Total bilirubin =50 ml/min (Cockcroft Gault formula); 9. Pregnant women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before entering the group, and they are willing to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of androtinib; 10. No immunosuppressive therapy; 11. Patients volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Participated in clinical studies of other drugs within four weeks before screening; 2. Those who have previously received apatinib or other VEGF inhibitors, such as bevacizumab, sorafenib, sunitinib, etc; 3. There are many factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 4. Symptomatic brain metastasis and cancerous meningitis (patients with stable symptoms who have completed treatment 21 days before admission can be admitted to the group, but they need to be confirmed without cerebral hemorrhage by brain MRI, CT or venography evaluation); 5. Patients with hypertension who can not be reduced to the normal range (systolic blood pressure > 140 mmHg / diastolic blood pressure > 90 mmHg) after antihypertensive drug treatment, have coronary heart disease >=grade II, arrhythmia (including QTc interval prolongation > 450 ms in men and 470 MS in women) and cardiac dysfunction (left ventricular ejection fraction =++ and the 24-hour urine protein quantity was more than 1.0 G; 7. Patients with other malignant tumors within 5 years; 8. Patients who have a history of psychoactive drug abuse and are unable to give up or have mental disorders; 9. With bleeding tendency or undergoing thrombolysis or anticoagulation (warfarin, heparin and similar substances) treatment; 10. Blood coagulation was abnormal (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 11. Those who have been confirmed to be allergic to docetaxel, irinotecan, enrotinib and / or their excipients; 12. Patients with definite bleeding tendency, including local active ulcer focus, and fecal occult blood (+ +) can not be included in the group; patients with history of black stool and hematemesis within 2 months; the researchers believe that patients with potential massive bleeding may have; 13. Pregnant or lactating women; 14. Patients with concomitant diseases that may seriously endanger the safety of patients or affect the completion of the study; 15. Patients considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;overall survival;the score criterion of Quality of Life ( QOL).;adverse event; | — |
Countries
China
Contacts
Public ContactWan Lixin
Nanyang Central Hospital
Outcome results
None listed