Esophagus cancer
Conditions
Interventions
Treatment group:DDP 30 mg/m2, D1, once a week
Cetuximab ß 500 mg/m2, D1, every two weeks
Tislelizumab 200 mg, D1, every three weeks
Radiotherapy plan: 50.4 Gy/28 fx, involved field irradiation princip
Sponsors
Chongqing Qianjiang Central Hospital (Chongqing University Affiliated Qianjiang Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The current subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance. 2. Age: 18 to 70 years old (at the time of signing the informed consent form); 3. ECOG score: 0-1 point; 4. Expected survival period >=12 weeks; 5. Pulmonary function tests show that FEV1 is greater than 1L; 6. Before treatment, CT or PET/CT confirmed no severe interstitial lung disease; 7. Thoracic and cervical esophageal squamous cell carcinoma (cT1b-4bN0M0, cT1-4bN+M0) that was confirmed by histological examination and/or cytological examination and evaluated by imaging assessment (refer to RECIST 1.1) as locally advanced and unresectable; And patients with unresectable locally advanced esophageal squamous cell carcinoma who have been judged by doctors as suitable for the treatment plan in this study; 8. No previous radiotherapy treatment has been received; Has not received EGFR monoclonal antibody drug treatment; Has not received drug treatment targeting related immune checkpoints such as PD-1 and PD-L1; However, thoracotomy, mediastoscopy, resection biopsy or similar surgical procedures can be accepted for the purpose of confirming the diagnosis, staging and surgical treatment of esophageal cancer. 9. According to the RECIST 1.1 efficacy evaluation criteria for solid tumors, the patient has at least one measurable lesion, that is, in CT or MRI detection, the longest diameter of a single lesion is >=10mm, or the lymph nodes are pathologically enlarged, and the shortest diameter of a single lymph node on CT scan is >=15mm; 10. The main organs are functioning well and meet the following criteria: (1) Blood routine test (under the condition of no blood transfusion and no correction with hematopoietic stimulating factor drugs within 14 days) : Hemoglobin (Hb) >=90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=80×10^9/L; (2) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60mL/min; (3) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) =50%; (5) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. (6) The doctor clinically determined that there was sufficient organ function. 11. Fertile subjects must use appropriate contraceptive methods during the study period and within 120 days after the study ends, have a negative serum pregnancy test within 7 days before enrollment in the study, and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions are not eligible for inclusion in this study: 1. Those with a risk of perforation after esophageal or tracheal stent implantation; 2. Those who have received systemic treatment for advanced or metastatic ESCC; 3. Those with a high risk of bleeding or perforation as judged by the investigator due to tumor invasion of adjacent organs (aorta or trachea) or the formation of fistulas; 4. Those who have received palliative treatment for local lesions within 2 weeks before the first dose; 5. Those who have received systemic treatment with traditional Chinese medicine with anti-cancer indications or immunomodulators (including thymosin, interferon, and interleukin) after signing the informed consent form; 6. Those who have received systemic immunosuppressants within 2 weeks before randomization, excluding local use of glucocorticoids through the nasal cavity, inhalation, or other routes, as well as physiological doses of systemic glucocorticoids (not exceeding 10mg/day of prednisone or equivalent), or glucocorticoids for the prevention of contrast agent allergy; 7. Those with any severe and/or uncontrolled diseases, including: (1) Uncontrolled blood pressure (systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg); (2) >= Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc >= 470ms), and >= Grade 2 congestive heart failure (NYHA classification); (3) Active or uncontrolled severe infection (>= CTCAE Grade 2 infection); (4) Liver cirrhosis, active hepatitis*; *Active hepatitis (for hepatitis B: HBsAg positive and HBV DNA test value exceeds the upper limit of normal; for hepatitis C: HCV antibody positive and HCV viral load test value exceeds the upper limit of normal); Note: Subjects with positive hepatitis B surface antigen or core antibody, or hepatitis C patients, who meet the inclusion criteria, need to receive continuous antiviral treatment to prevent viral activation. (5) Active syphilis; (6) Renal failure requiring hemodialysis or peritoneal dialysis; (7) Those with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. Poorly controlled diabetes (fasting blood glucose [FBG] > 10mmol/L); 9. Those who have undergone major surgery, incisional biopsy, or significant traumatic injury within 28 days before the start of study treatment; or those with long-term unhealed wounds or fractures; 10. Those who have experienced severe symptomatic arterial or venous thrombotic events within 6 months before the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; 11. Those known to be allergic to the active ingredients or excipients of the study drugs cetuximab ß, tislelizumab, cisplatin, etc.; 12. Other situations deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete remission rate under CT/MRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;DCR;DOR;2-year overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactWang Dong
Chongqing Qianjiang Central Hospital (Chongqing University Affiliated Qianjiang Hospital)
Outcome results
None listed