esophageal squamous cell carcinoma
Conditions
Interventions
Case series:Camrelizumab + Stereotactic Body Radiation Therapy
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced esophageal squamous cell carcinoma confirmed by histology or cytology; 2. Received systematic treatment once before; 3. Aged >=18 years old, male or female; 4. At least one measurable lesion according to the therapeutic efficacy evaluation criteria for solid tumors (RECIST 1.1); 5. ECOG 0 ~ 2; 6. Expected survival >=12 weeks; 7. The function of vital organs meets the following requirements (no blood components and cell growth factor are recommended 2 weeks before treatment): (1) Absolute count of neutrophils (ANC) >=1.5x10^9/L; (2) Platelet >=100x10^9/L; (3) Hemoglobin >=9g/dL; (4) Serum albumin >=2.8g/dL; (5) Bilirubin =50mL/min; (7) Activated partial thromboplastin time (APTT) and international standardized ratio (INR) & LT; 1.5-fold ULN (for treatment with stable doses of anticoagulants such as LMWH or warfarin and INR within the expected therapeutic range of anticoagulants); 8. Fertile female subjects shall undergo a urine or serum pregnancy test within 72 hours prior to the first study drug administration and prove negative, and shall be willing to use an effective method of contraception between the trial period and 3 months after the last study administration of Karillizumab. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of Karillizumab; 9. Subjects voluntarily participate in this study, sign informed consent, have good compliance and cooperate with follow-up; 10. The investigator determined that the patient could receive Camrelizumab combined with SBRT.
Exclusion criteria
Exclusion criteria: 1. Other malignant neoplasms diagnosed within 5 years prior to the first use of the study drug, except for basal cell cutaneous carcinoma, squamous cell cutaneous carcinoma and/or cervical carcinoma in situ and/or breast cancer which have been effectively removed; 2. A history of gastrointestinal perforation and/or fistula within 6 months before the first medication; 3. Obvious invasion of tumor into adjacent organs of esophageal lesion (aorta or trachea) leads to higher risk of bleeding or fistula; 4. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 5. Has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included if hormone replacement therapy is normal));Patients with vitiligo or childhood asthma that has been completely alleviated can be included without any intervention as adults, but patients with asthma requiring medical intervention with bronchodilators cannot be included; 6. Uncontrolled cardiac clinical symptoms or diseases, such as :(1) NYHA grade II or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 7. Severe infection (CTC AE > level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.;Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotin therapy, with the exception of prophylactic antibiotic use; 8. History or evidence of interstitial lung disease or active non-infectious pneumonia is known; 9. Patients with congenital or acquired immune deficiency (such as HIV-infected persons), active hepatitis B (2000 IU/mL or =104 copies /mL of HBV-DNA) or hepatitis C (antibody positive for hepatitis C and HCV-RNA higher than the lower detection limit for analytical methods); 10. Previous experience of other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1; 11. Is known to be allergic to macromolecular protein preparations, or to any component of Carrelizumab, or to be allergic, hypersensitive or contraindicated to fluorouracil, platinum or any component used in its preparations; 12. Subjects requiring systematic treatment with corticosteroids (> 10mg/ day equivalent of prednisone) or other immunosuppressive agents within 14 days prior to the first use of the study drug; 13. The toxicity of previous anti-tumor therapy did not return to < CTC AE level 1 (except hair loss) or the level specified in the inclusion/exclusion criteria; 14. Women who are pregnant or breastfeeding; 15. In the investigator's judgment, the subject has other factors that could force him or her to terminate the study in the course of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, severely abnormal laboratory test values, and family or social factors that could affect the subject's safety or the conditions under which the study data were collected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactXiancheng Liu
Affiliated Hospital of Nantong University
Outcome results
None listed