Esophageal cancer
Conditions
Interventions
Observation group:N/A
Sponsors
Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 70 years old, gender not limited; 2.Esophageal cancer confirmed by histology or cytology; 3.Accept radiotherapy for the affected field of esophageal cancer; Simultaneous use of monotherapy chemotherapy (Tegio and paclitaxel (albumin bound)) and PD-1 inhibitor therapy during radiotherapy;
Exclusion criteria
Exclusion criteria: 1. Combined esophageal fistula, perforation, or acute infectious diseases 2. History of chest radiotherapy; 3. Having any active autoimmune disease or history of autoimmune disease (e.g., uveitis, systemic lupus erythematosus, hypophysitis, vasculitis, myocarditis, nephritis — if hormonal replacement therapy is effective, these may be included), or use of immunosuppressive drugs within the past 28 days, except for steroid treatment of radiotherapy toxicity; 4. Previously received or currently receiving other PD-1 antibody therapy or other PD-1/PD-L1 targeted immunotherapy, or currently participating in other interventional clinical studies for treatment; 5. Received other antitumor treatments (including herbal treatments with antitumor effects) within 4 weeks prior to the first study dose; received long-term systemic immunotherapy or hormone therapy (except physiological replacement therapy, e.g., oral thyroid hormone for hypothyroidism) within 4 weeks prior to the first study dose; or received other experimental drugs or interventional clinical study treatments within 4 weeks prior to the first study dose; 6. Patients with uncontrolled clinical cardiac symptoms or diseases, such as (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. Congenital or acquired immune deficiency (e.g., HIV infection), active hepatitis B (HBV-DNA = 10^4 copies/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection), or active pulmonary tuberculosis; 8. History of malignant tumors other than esophageal cancer within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix; as judged by the investigator, subjects with other factors that may force them to withdraw from the study, such as severe diseases requiring comorbidity treatment (including psychiatric disorders), or family or social factors that may affect the subject's safety or trial data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events,AEs;Disease Control Rate,DCR;Progression-Free Survival,PFS;Time to Response,TTR;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactHan Zhang
Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)
Outcome results
None listed