Esophageal cancer
Conditions
Interventions
treatment group:sintilimab combined with radiotherapy and S-1 chemotherapy
Control group:radiotherapy and S-1 chemotherapy
Sponsors
Huai'an First People's Hospital
Eligibility
Sex/Gender
All
Age
70 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed squamous cell carcinoma; 2. At least one measurable lesion according to RECIST 1.1; 3. Stage (AJCC 8th) IIa-IVa; 4. Aged 70-85 years old; 5. ECOG score of 0 to 1; 6. No esophageal perforation or active esophageal bleeding, and no obvious invasion of large trachea or thoracic vessels; 7. Hemoglobin (HB) >= 100 g/L,Platelet (PLT) >= 80 x 10^9/L,The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L; 8. Serum creatinine (Cr) = 60 mL/min; 9. TBIL = 3.0 g/dL; 10. No history of interstitial pneumonia or previous interstitial pneumonia; 11. The expected survival time is >= 12 weeks; 12. Weight greater than 40 Kg,Body mass index (BMI) ranged from 18 to 28 kg /m2; 13. The total length of the primary tumor and metastatic lymph nodes was less than 12cm;
Exclusion criteria
Exclusion criteria: 1. Small-cell esophageal carcinoma, esophageal adenocarcinoma, or other mixed carcinoma confirmed by histology or cytology; 2. Received thoracic radiotherapy, chemotherapy, immunotherapy, targeted therapy, or surgical resection of esophageal cancer before the initiation of the trial; 3. The patient 's tumor was closely related to the trachea and bronchus or large vessels and that had been assessed by the investigator as being at high risk for perforation and massive bleeding. Tracheoesophageal fistula, complete esophageal obstruction, deep esophageal ulcer, and esophageal perforation were occurred within 24 weeks before enrollment; 4. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a history of prior interstitial pneumonia; 5. Active or documented autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., Colitis or Crohn's disease], diverticulitis (other than diverticulitis), systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [gr; 6.Uncontrolled complications, including but not limited to persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal illness with diarrhea; 7.History of active primary immunodeficiency, active infection, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging findings, and workup for tuberculosis according to local treatment principles), hepatitis B (known HBsag-positive results), hepatitis C virus or HIV(positive for HIV1/2 antibodies). Patients with previous HBV infection or HBV remission (defined as the presence of hepatitis B core antibodies [anti-HBc] without HBsAg) were eligible, and patients who were positive for hepatitis C (HCV) antibodies were eligible only if they were negative for HCVRNA on polymerase chain reaction; 8.Current or previous use of immunosuppressive drugs within 14 days before the administration of immunotherapy. The following exceptions to this standard are: intranasal, inhaled, topical, or locally injected steroids (e.g., intra-articular injections); 1.systemic corticosteroids, equivalent to 10mg/ day of prednisone or its equivalents; 2.steroid hormones, used as pretreatment for hypersensitivity (e.g., CT scan pretreatment); 9.Patients who do not understand or may not comply with trial requirements; 10.Patients with a history of other malignancies except curable skin cancer (non-melanoma), carcinoma in situ of the cervix, or malignant disease cured for more than 5 years; 11.Some obvious diseases that the investigator thought should be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Objective Response Rate;Toxic and Adverse Reaction;Failure Mode; | — |
Countries
China
Contacts
Public ContactWeiguo Zhu
Huai'an First People's Hospital
Outcome results
None listed