Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental Group:Radiotherapy and Sacituzumab Tirumotecan
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. Age 18 or above, male or female; 3. Patients who have undergone surgical treatment for radical esophageal cancer, and the postoperative pathology is esophageal squamous cell carcinoma, and they have received chemotherapy, immunotherapy or other systemic therapy in the past, and there is locoregional progression; 4. Patients with local/regional recurrence after surgery, including: anastomosis, tumor bed, regional lymph nodes (including supraclavicular lymph nodes, mediastinum, left gastric and celiac dry lymph nodes, excluding bilateral hilar lymph nodes); 5. Measurable lesions that meet the definition of efficacy evaluation criteria for solid tumors (RECIST1.1) before radiotherapy; 6. ECOG: 0~1 point (see Annex 1); 7. Archived postoperative tumor tissue samples must be provided for biomarker (e.g., TROP2) analysis, and the sample type is FFPE tumor tissue blocks or at least 5 unstained FFPE tumor tissue sections with a thickness of 3-5 µm. 8. Expected survival >=3 months; 9. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of the screening examination): a) Absolute neutrophil count (ANC) >=1.5×10?/L; b) platelet >=100×10?/L; c) hemoglobin >=9g/dL; d) serum albumin>=2.8 g/dL; e) total bilirubin = 60 mL/min (calculated according to the Cockcroft-Gault formula, see Annex II); g) International normalized ratio (INR) and activated partial thromboplastin time (APTT) < = 1.5× ULN (screening may be performed for anticoagulation at stable doses such as low molecular weight heparin or warfarin with an INR within the expected therapeutic range of the anticoagulant).
Exclusion criteria
Exclusion criteria: 1. Combined distant regional lymph node and/or organ metastasis; 2. Previous history of esophageal fistula caused by primary tumor invasion; 3. There is a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation; 4. Patients with serious postoperative complications after esophageal cancer surgery and have not recovered, including but not limited to: anastomotic leakage, pneumonia, etc.; 5. Subjects with poor nutritional status and weight loss of =10% within 2 months before screening had no significant improvement after business maintenance intervention; 6. Major surgery or serious trauma within 4 weeks prior to the first use of study drug; 7. Presence of uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; 8. Patient has received or is receiving any of the following treatments after confirmed local/regional recurrence: a) Subjects who require systemic treatment with corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to the first use of study drug, except for the use of corticosteroids for local inflammation of the esophagus and prevention of allergies, nausea and vomiting. In other special circumstances, it is necessary to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at doses > 10mg/day prednisone efficacy doses are permitted; b) Those who have been vaccinated with anti-tumor vaccines or have received live vaccines within 4 weeks before the first dose of the study drug; 9. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Patients with vitiligo or cured asthma/allergies of the same age, who do not require any intervention after adulthood; Patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus on stable doses of insulin may be included; 10. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 11. Subjects with uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 12. Serious infection (CTC AE> grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization; Baseline chest imaging showing active lung inflammation, symptoms and signs of infection present in the 2 weeks prior to the first dose of study drug, requiring oral or intravenous antibiotic therapy, with the exception of prophylactic antibiotics; 13. Have a history of interstitial lung disease, a history of non-infectious pneumonia, and pulmonary function tests confirm >=grade 3 pulmonary insufficiency; 14. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Duration of Response;Adverse Events; | — |
Countries
China
Contacts
Public ContactWencheng Zhang
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed