Do not treat advanced esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Adebelimumab combined with liposomal irinotecan
Sponsors
The Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender unlimited; 2. Histopathologically or cytologically confirmed advanced stage II-IVA unresectable/unresectable esophageal squamous cell carcinoma that, as assessed by the principal investigator, has been deemed appropriate for dCRT; 3. Have not received systematic anti-tumor therapy; 4. ECOGPS: 0 ~ 1; 5. Have adequate organ and bone marrow function, defined as follows: hemoglobin >= 9.0 g/dL, absolute neutrophil count >=1.5 × 109/L, platelet count>=100 × 109/L, total bilirubin =3.0g/dL Serum creatinine 60mL/min or according to Cockcroft-Gault Formula (using actual body weight) to calculate creatinine clearance > 60 mL/min: Male: creatinine clearance = (body weight x (140-age)) / (72 x serum creatinine) Female: creatinine clearance = (body weight x (140- age))/(72xserum creatinine)x0.85 where CL=mL/min; serum creatinine=mg/dL; 6. Patients with active HBV infection should receive antiviral treatment for more than 2 weeks according to local antiviral treatment guidelines before enrollment, and should continue treatment for 6 months after study drug treatment; 7. The hepatitis C virus (HCV) antibody test is negative during screening, or the HCV antibody test is positive during screening, but the subsequent HCV RNA test is negative; 8. Expected survival period>=12 weeks; 9. The patient signed the informed consent form and voluntarily participated in this study.
Exclusion criteria
Exclusion criteria: 1. Have a high risk of esophageal fistula, such as a history of esophageal fistula or related symptoms, or a primary tumor infiltrating large blood vessels or trachea; 2. Evidence of complete esophageal obstruction, not suitable for treatment; 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis (excluding diverticular disease), systemic lupus erythematosus, sarcoidosis syndrome or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc.]). The following are exceptions to this criterion: (a) patients with vitiligo or alopecia; (b) patients with hypothyroidism (eg, after Hashimoto syndrome) who are receiving stable hormone replacement therapy; (c) any chronic skin disease not requiring systemic therapy. disease; (d) patients with no active disease within the past 5 years may be included, but only after consultation with the study physician; (e) patients with celiac disease that can be controlled by diet alone; 4. Active infections, including tuberculosis (clinical evaluation includes clinical history, physical examination, radiographic findings, and tuberculosis screening in accordance with local treatment principles); 5. 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 gastroenteric disease with diarrhea, Or a mental illness/social condition that limits study compliance, significantly increases the risk of developing AE, or impairs the patient's ability to provide written informed consent; 6. The thyroid function has been abnormal in the past, and the thyroid function still cannot be maintained within the normal range under the condition of drug treatment; 7. Patients who are currently using or have used immunosuppressive drugs within 14 days before the first dose of Adebelimumab. The following are exceptions to this standard: (a) intranasal, inhaled, topical, or locally injected steroids (eg, intraarticularly); (b) systemic glucocorticoids not exceeding physiologic doses, equivalent to 10 mg/day of prednisone (c) steroids as pre-treatment for hypersensitivity reactions (e.g., pre-treatment for CT scans); 8. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 9. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 10. Live attenuated vaccine should be administered within 30 days prior to the first administration of the investigational drug. Note: If enrolled, patients should not receive the live vaccine during treatment with the study drug and within 30 days after the last administration of the study drug; 11. Known allergic or hypersensitive reactions to any investigational drug or to any excipients thereof; 12. Enrolling in another clinical study at the same time, unless the study is an observational (non-interventional) clinical study, or the follow-up period of the interventional study; 13. Other situations that the researcher determines are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival for 1 year;Imaging Studies;White blood cells, red blood cells, and urinary protein in urine;Whole blood cell count and classification;ALT,AST,ALP,CK,CK-MB,ALB,TBIL,DBIL?GLU?BUN?Cr?Serum electrolyte.;INR,APTT,FIB,TT;TSH,FT3,FT4;Body temperature, pulse, blood pressure, respiratory rate, and resting oxygen saturation;Cardiac electrical activity and cardiac function; | — |
Secondary
| Measure | Time frame |
|---|---|
| LVEF;HIVPT;Syphilis;HBsAg,HBsAb,HBcAb,HBeAg,HBeAb;HCV-RNA.; | — |
Countries
China
Contacts
Public ContactFang Ma
The Second Xiangya Hospital, Central South University
Outcome results
None listed