Esophageal cancer
Conditions
Interventions
Case series:Papbolizumab
Sponsors
Air Force Specialty Medical Center, PLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study and have good compliance. They can cooperate with the requirements of the study to complete observation and follow-up, and sign the informed consent; 2. The patients with esophageal squamous cell carcinoma confirmed by histopathological examination were in the middle and advanced stage of esophageal carcinoma. They had not received other anti-tumor drugs or immunodrugs besides the experimental drugs in the previous 4 weeks, and could receive specialized anti-tumor treatment; 3. Subjects must not be suitable for the radical surgical method; 4. the time from the end of previous (new) adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence >6 months; 5. According to RECIST V1.1, there is at least one measurable lesion; 6. ECOG<=2, in line with chemotherapy indications; 7. Patients who have lost less than 10% of their body weight in the past six months and are able to withstand radiotherapy; 8. Heart function: ECG was generally normal; 9. Between the ages of 18 and 70, for both men and women; 10. 7 days before the first use Canon of laboratory tests confirmed that the patients' bone marrow, liver and heart function to satisfy the following conditions: white blood cells (WBC) or 3000 / (including L, neutrophils (ANC) the absolute count of 1500 or higher/(including L, platelet p / 100000 (including L, acuity 9.0 g/dL and hemoglobin ? AST and ALT <=2.5 ULN, ALKALINE phosphatase <=4 ULN, total bilirubin <=1.5 ULN; Serum creatinine <=1.5 ULN, blood urea nitrogen (BUN) <= 2.5 ULN; International standardized ratio of prothrombin time or partial thrombin time <=1.5 ULN; Left ventricular ejection fraction (LVEF) as assessed by Doppler ultrasound was greater than or equal to 60%; 11. Female: contraception during and within 6 months after treatment; Non-lactation period; Male: avoid pregnancy during and 6 months after treatment.
Exclusion criteria
Exclusion criteria: Women who are pregnant, lactating or fertile but do not use contraception; Existing severe acute infection, there are suppurative and chronic infection, the wound does not recover; Esophageal perforation (esophagotracheal fistula or the possibility of esophageal tracheal fistula); Received other anti-tumor therapy within 4 weeks before enrollment; Abnormal coagulation function, bleeding tendency (e.g., active gastrointestinal ulcer) or symptoms receiving thrombolytic or anticoagulant therapy; Original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Suffering from uncontrollable neurological, mental illness or mental disorder, poor compliance, inability to cooperate and describe the treatment response; Severe cirrhosis, severe renal insufficiency; Always received PD - 1 resistance, resistance to PD - L1, PD - L2 resistance, resistance to CD137 antibody or anti CTLA - 4 college therapy, or any other T cells stimulate or total checkpoint pathways for specific target antibody or drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security; | — |
Countries
China
Contacts
Public ContactYan Maohui
Air Force Specialty Medical Center, PLA
Outcome results
None listed