esophageal squamous cell carcinoma
Conditions
Interventions
Test Group:radiotherapy (IMRT, 95%PTV 50-60Gy/1.8-2Gy/25-30f)?2weeks after?adebrelimab(20mg/kg i.v.d1,Q3w)(single drug, for 1 year)
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form in writing; 2. Age >=65 years, any gender; 3. Confirmed diagnosis by histology or cytology; 4. Elderly patients with locally advanced esophageal cancer who are unable or unwilling to undergo resection and cannot tolerate chemotherapy due to advanced age; 5. ECOG performance status 0–1 (see Appendix 2 for ECOG criteria); 6. Expected survival >=3 months; 7. No severe dysfunction of hematopoietic, cardiac, pulmonary, hepatic, or renal systems, and no immune deficiency; 8. Neutrophil count >=1.5 × 10^9/L; hemoglobin >=9 g/dL; platelets >=100 × 10^9/L; total bilirubin >=1.5 times the upper limit of normal; AST (SGOT) and ALT (SGPT) <=2.5 times the upper limit of normal; creatinine = 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. Those who have any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after effective hormone replacement therapy), etc.) and have a history of using immunosuppressants within 28 days However, the use of hormones to deal with the toxicity caused by radiotherapy and chemotherapy is excluded. 3. Adverse events of grade greater than 2 caused by treatment received before the first use of the study drug that have not yet recovered (i.e., have reached grade 1 or baseline levels) and are determined by the investigator to be difficult to recover rapidly (such as neurotoxicity) may be enrolled. 4. As determined by the researchers, there is still non-infectious pneumonia caused by previous radiotherapy and chemotherapy. 5. Have previously received or are currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1; 6. Known to be allergic to large molecule protein preparations, or to any components in Adbelimab (SHR-1210) and its preparations; 7. Suffering from uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction has occurred within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8. Suffering from congenital or acquired immune deficiency (such as HIV-infected individuals), active hepatitis B (HBV-DNA=104 copies/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the detection limit of the analytical method), or active tuberculosis; 9. Active infection or unexplained fever > 38.5? within 2 weeks before enrollment (as determined by the researcher, the subjects with fever caused by tumors can be enrolled); 10. Fertile men or women who are unwilling to take contraceptive measures in the trial, and female patients who are pregnant or breastfeeding; 11. If the investigator determines that the subject has other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, family or social factors that may affect the subject's safety or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Disease control rate (DCR);Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression-free survival period (PFS); | — |
Countries
China
Contacts
Public ContactYaqun Zhu
The Second Affiliated Hospital of Soochow University
Outcome results
None listed