esophageal squamous cell carcinoma
Conditions
Interventions
Group A (Radiation Therapy and Immune Therapy Group):Radiotherapy combined with chemotherapy and immunotherapy.
Group B (Radiotherapy and Chemotherapy Group):Radiotherapy and chemotherapy.
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
70 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood this study and voluntarily signed the informed consent form; 2. Age = 70 years old; 3. Presence of measurable lesions according to the RECIST criteria; 4. Diagnosed as esophageal squamous cell carcinoma by histopathology; 5. Staged as locally advanced patients I-IVB (8th edition AJCC IVB stage for ESCC includes lymph node metastasis above the clavicle and around the celiac trunk); 6. ECOG performance status score of 0-1; 7. Expected survival of = 6 months; 8. Function of important organs must meet the following requirements: 1)Hematological tests must meet the standards (no transfusion or infusion of blood products, no use of G-CSF and other hematopoietic stimulating factors within 14 days): A. Hemoglobin (Hb) = 100 g/L; B. Absolute neutrophil count (ANC) = 1.5×10^9/L; C. Platelet count (PLT) = 100×10^9/L; 2)Biochemical tests must meet the following standards: A. Total bilirubin (TBIL) 60 ml/min (using the Cockcroft-Gault formula). D. The urinalysis results indicate that urinary protein (UPRO) is less than 2+ or the 24-hour urinary protein quantification is less than 1g; 3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 4) Prothrombin time =1.5 times the upper limit of normal (ULN), International Normalized Ratio (INR) =1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Allergic to treatment drugs; 2. Histologically or cytologically confirmed mixed squamous carcinoma, small cell neuroendocrine carcinoma, and sarcomatoid carcinoma; 3. Evidence of distant metastasis; 4. Exclude patients diagnosed with other malignancies within the past 5 years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has been effectively treated, and in situ cervical cancer and/or breast cancer that has been effectively excised; 5. Patient received attenuated live vaccines within 30 days of first dosing or is expected to receive such vaccines during the study period; 6. Patient has active pulmonary, pericardial, or systemic infection; 7. Any patient with active autoimmune disease or a history of autoimmune diseases, or active hepatitis B/C; 8. Patient underwent major surgery within 4 weeks prior to enrollment or has wounds from surgery that have not fully healed; 9. Imaging studies show tumor invasion into major blood vessels, or, in the judgment of the investigator, the tumor is highly likely to invade major blood vessels during the subsequent study period, potentially causing fatal hemorrhage. 10. Patients with a history of substance abuse involving psychotropic medications who are unable to discontinue or those with psychiatric disorders; 11. Patients allergic to gadolinium contrast agents or those with claustrophobia or other contraindications to undergo MRI with contrast enhancement; 12. Any unstable systemic disease including active infection, poorly controlled hypertension, unstable angina pectoris, angina pectoris that began within the last 3 months, congestive heart failure (New York Heart Association [NYHA] = II grade), myocardial infarction within the last 6 months requiring medication, and severe arrhythmias needing treatment; 13. Patients with a history of immunodeficiency, including but not limited to HIV-positive test results or those with other acquired or congenital immune deficiency diseases, or those with a history of organ transplantation; 14. Patients currently participating in an interventional clinical trial or those who have received other experimental drugs or investigational devices within 4 weeks prior to the first dose; patients not fully recovered from toxicities and/or complications caused by any intervention measures at the time of the first dose (i.e., = Grade 1 or returned to baseline, excluding fatigue or alopecia); 15. Known significant history of liver disease, including but not limited to known hepatitis B virus (HBV) infection with HBV DNA positivity (=1×10^3/ml); known hepatitis C virus (HCV) infection with HCV RNA positivity (=1×10^3/ml), cirrhosis, etc.; 16. Presence of high-risk factors for radiation therapy complications such as bleeding, fistula, perforation, etc.; 17. Patients deemed unsuitable for inclusion by the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Rate,OSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Health-related quality of life, HRQoL;Objective response rate, ORR;Disease control rate, DCR;Duration of remission, DOR; | — |
Countries
China
Contacts
Public ContactGehong
Henan Cancer Hospital
Outcome results
None listed