esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Intensity-modulated radiation therapy
Tegaserod: 40-60mg, po, D1, BID, 1-14d/21d.
Cetuximab ß 500 mg/m2, administered intravenously (IV) on Day 1, every 2 weeks (Q2W), for a total o
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understands this study and voluntarily signs the informed consent form; 2. Age >=65 years; 3. Has measurable lesions according to RECIST criteria; 4. Diagnosed with esophageal squamous cell carcinoma by histopathology; 5. Stage I–IVB (AJCC 8th edition; for stage IVB ESCC, only includes supraclavicular and celiac trunk–peripheral lymph node metastases); 6. ECOG performance status 0–1; 7. Expected survival >=6 months; 8. Major organ function meets the following requirements: 1) Complete blood count must meet the following criteria (no transfusion of blood or blood products within 14 days; no use of G-CSF or other hematopoietic stimulating factors for correction): 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) Biochemistry tests must meet the following criteria: A. Total bilirubin (TBIL) 60 mL/min (Cockcroft–Gault formula); D. Routine urinalysis shows urine protein (UPRO) = the lower limit of normal (50%); 4) Prothrombin time <=1.5× ULN, and international normalized ratio <=1.5× ULN.
Exclusion criteria
Exclusion criteria: 1. Allergy to the study treatment drugs; 2. Histological or cytological confirmation of mixed squamous carcinoma, small-cell neuroendocrine carcinoma, or sarcomatoid carcinoma; 3. Evidence of distant metastasis; 4. Diagnosis of another malignancy within 5 years prior to study entry, except for effectively treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast that has been effectively resected; 5. Receipt of a live attenuated vaccine within 30 days of the first dose or anticipated vaccination with a live attenuated vaccine during the study period; 6. Active pulmonary, pericardial, or systemic infection; 7. Any active autoimmune disease or history of autoimmune disease, or active hepatitis B/hepatitis C; 8. Major surgery within 4 weeks prior to enrollment, or surgical wounds not fully healed; 9. Imaging shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade major vessels during the study, causing fatal massive hemorrhage; 10. History of abuse of psychotropic drugs that cannot be discontinued, or psychiatric disorders; 11. Allergy to gadolinium contrast agents, or claustrophobia or other factors that prevent contrast-enhanced MRI; 12. Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina with onset in the past 3 months, congestive heart failure (New York Heart Association [NYHA] class = II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, etc.; 13. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 14. Currently participating in an interventional clinical study, or having received other investigational drugs or investigational device treatment within 4 weeks prior to the first dose; prior to first dosing, not fully recovered from toxicities and/or complications caused by any intervention (i.e., = 1 × 10^3/ml); known hepatitis C virus (HCV) infection with positive HCV RNA (>= 1 × 10^3/ml), or cirrhosis, etc.; 16. High-risk factors for radiotherapy complications such as bleeding, fistula, perforation, etc.; 17. Patients deemed unsuitable for enrollment at the investigator’s discretion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Duration of relief;2-year overall suvival rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactZang Chunbao
Anhui Provincial Cancer Hospital
Outcome results
None listed