Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer
Trial Parameters
Brief Summary
We intend to conduct a prospective single-arm clinical study to explore the efficacy and safety of immunochemotherapy in neoadjuvant therapy in elderly patients with advanced esophageal squamous cell carcinoma. Most previous randomized controlled studies (such as the 5010 study) have excluded older patients ≥70 years of age. However, in the real world, elderly patients with esophageal cancer account for a large number of patients, and elderly people have many complications and poor tolerance to treatment, which limits the application of synchronous chemoradiotherapy in this group. There is no standard treatment plan for patients over 70 years old, and the purpose of this study is to explore the effectiveness and safety of neoadjuvant immunochemotherapy in the treatment of this group of elderly people.
Eligibility Criteria
Inclusion Criteria: 1. Age: ≥70 years (no age limit, with super-elderly patients, such as those ≥80 years, the investigator will assess whether to include them based on the actual situation; gender is not restricted). 2. ECOG PS: 0-1 points; and G8 score ≥14 points. (Patients with G8 scores \<14 points will undergo Comprehensive Geriatric Assessment (CGA), and the investigator will decide on inclusion based on the assessment results). 3. Pathologically confirmed esophageal squamous cell carcinoma. 4. No history of prior anti-tumor treatment. 5. Clinical stage is T2-4aN0M0 or T1-4aN+M0, and MDT evaluation deems the patient operable (AJCC staging eighth edition). 6. Adequate organ function: * Hematological tests (within 7 days, without the use of hematopoietic growth factors and transfusion): Granulocyte count ≥1.5×10\^9/L, platelet count ≥80×10\^9/L, hemoglobin ≥80g/L. * Biochemical tests: Total bilirubin ≤1.5×ULN (upper limit of normal), blood alanine aminotransferase (ALT) or aspartat