Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Camrelizumab+DCF dosage regimen
Control group:DCF dosage regimen
Sponsors
Xijing Hospital of Digestive Diseases, Xijing Hospital, the Fourth Military Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years patients underwent esophageal squamous cell carcinoma; 2. Patients with esophageal squamous cell carcinoma diagnosed by histology; 3. The primary treatment of patients with ESCC had no previous operation; 4. According to eighth edition of TNM stages, patients were divided into T2N0~1M0 or T3~4aN1~2M0 esophageal squamous cell carcinoma; 5. ECOG PS score is 0-1; 6. Estimated lifetime >=3 months; 7. At least one measurable lesion (CT examination diameter >= 1cm, other examination methods >= 2cm); 8. Patients who can be received liquid diet at least; no signs of the before esophageal perforation; Without distant metastasis; The patients also can tolerate the operation; 9. The function of main organs is normal, it must meet the following mechanical criteria: (1) Blood tests (no blood or blood products transfusion within 14 days; no using G-CSF or other hematopoietic growth factor products): HB>=100 g/L; ANC>=1.5x10^9/L; PLT>=100x10^9/L; (2) Blood biochemical examination: TBIL 50 mL/min (Cockcroft-Gault formula); (3) Lung function was normal or mild and moderate abnormality (VC%>60%, FEV1>1.2L, FEV1%>40%, DLco>40%); (4) Cardiovascular function: stage I to II; 10. From the beginning of the screening period to within 3 months after the last use of the study drug, fertile women and men must voluntarily use recognized and effective contraceptive measures; 11. Subjects were volunteered to join the study, signed the informed consent form, good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients were ineligible to meet the inclusion criteria of pathological type and primary site; 2. Patients allergic to drugs such as Camrelizumab, lobaplatin, docetaxel, etc.; 3. It has the risk of esophageal perforation, or existence of the esophageal ulcer and contraindications to radiotherapy; 4. With obvious evidence of distant metastases; 5. Patients who has operated therapy, radionuclide therapy, chemotherapy, or molecular targeted therapy; 6. Patients who suffered other malignant tumors; 7. With severe lung or heart disease; 8. Serious active infections, or appear fever of unknown origin>38.5 degree C within 2 weeks before randomization; 9. Serious acute infections, or existence of blood, liver, kidney dysregulation; 10. Patients with active autoimmune diseases including HIV, immune deficiency, or organ transplantation; 11. Subjects who required treatment with corticosteroids (>10mg/day of prednisone) or other immunosuppressants within 14 days before the first use of the study drug. If the patients without history of the active autoimmune diseases, it is allowed to inhale or topically use steroids and the replacement of corticosteroids with a therapeutic dose of > 10mg / day prednisone; 12. Patients with hepatitis B (HBV DNA >=2000 IU/mL or 104 copies/mL) or hepatitis C; 13. Patients who were vaccinated within 3 months before treatment; 14. It is in the period of acute and chronic tuberculosis infection (T-spot positive test, suspicious tuberculosis on chest radiograph); 15. Patients who have the history of drug or alcohol abuse; 16. patients who participated in another clinical study 4 weeks before or during the study; 17. Patients who cannot be intravenous infusion; 18. Patients who have the history of peptic ulcer, bleeding tendency and gastric perforation; 19. Patients with hypertension who cannot be reduced to normal range by antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); patients with unstable angina pectoris; patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; patients with arrhythmia (including QTCF: male >=450 ms, female >=470 MS) need long-term use of antiarrhythmic drugs New York Heart Association grade II or above; 20. According to the researcher judgment, there are other factors that may cause the subject to be forced to terminate the study, such as other serious diseases (including mental diseases), serious laboratory examination value abnormality, family or social factors, and other factors which may affect the safety of the subject or the collection of experimental data; 21. Staff of the research center, partner or first degree relative of the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;3-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;ORR;DFS; | — |
Countries
China
Contacts
Public ContactJianjun Yang
Xijing Hospital of Digestive Diseases, Xijing Hospital, the Fourth Military Medical University
Outcome results
None listed