Esophagus Cancer
Conditions
Interventions
trial group:PTX and LBP
Control group:PTX and DDP
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences; Yunnan Cancer Hospital; The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male and female; 2. Esophageal cancer was diagnosed by imaging, histopathology or cytology, and its pathological type was squamous cell carcinoma. 3. Patients with thoracic esophageal squamous cell carcinoma (UICC-TNM stage, 8th edition) whose clinical stage is stage II-III before chemotherapy. 4. Physical condition ECOG PS:0 or 1; 5. The estimated survival time is more than 6 months. 6. There was no contraindication of operation before operation. 7. Laboratory inspection indicators meet the following requirements: (1) Bone marrow function: hemoglobin (Hb) > 90g/L; white blood cell count (WBC) > lower limit of normal value; neutrophil absolute value (ANC) > 1.5 *10^9/L; platelet count 55 ml/min; (3) Liver function: total bilirubin < ULN * 1.5; ALT and AST < ULN * 2.5; (4) Coagulation function: the international standardized ratio of prothrombin time < ULN * 1.5, and part of thromboplastin time is within the normal range; 8. No treatment for esophageal cancer has been received in the past, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy. 9. Women of childbearing age agree to contraception within 6 months after the study period and the end of the study; women with negative serum or urine pregnancy test within 7 days before the study group and non-breast-feeding patients; men with consent to contraception within 6 months after the study period and the end of the study; 10. Those who had not participated in other drug clinical trials within 4 weeks before admission; 11. Subjects can understand this study and sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Anyone who is known to be allergic to any component of the test drug or excipient; 2. Complication with severe cardiovascular diseases, including uncontrollable hypertension (BP >= 160/95mmHg), unstable angina pectoris, history of myocardial infarction in the past six months, congestive heart failure > NYHA II, severe arrhythmia and pericardial effusion; 3. Complicated with severe ADH abnormal secretion syndrome and poorly controlled diabetes mellitus: those who need more than 40 units of insulin a day for continuous administration, or those who use or do not use insulin within 40 units a day, but whose fasting blood sugar is still above 14 mmol/L and HbA1c is above 9.0; 4. Long-term use of anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues for more than 6 months is required, but does not include the use of small doses of warfarin (=CTCAE 2) occurred. 9. Severe infections occurred within one week before the start of the study, requiring intravenous antibiotics, antifungal or antiviral treatment. 10. suffering from severe mental illness and poor compliance; 11. Researchers believe that the case is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;pCR;DFS;1 year, 3 years, 5 years survival rate;ORR?DCR;safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactYin Li;Gaofeng Li;Junfeng Liu
Cancer Hospital Chinese Academy of Medical Sciences;Yunnan Cancer Hospital;The Fourth Hospital of Hebei Medical University
Outcome results
None listed