Esophageal squamous cell carcinoma
Conditions
Interventions
Test group:1.Neoadjuvant Immunochemotherapy: Consisting of tislelizumab (200 mg, once every three weeks, for a total of three cycles) combined with chemotherapy (nab-paclitaxel and carboplatin, every
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 79 years, no restriction on sex; 2. Newly diagnosed esophageal squamous cell carcinoma (ESCC); 3. Histologically confirmed squamous cell carcinoma of the esophagus by biopsy; 4. Clinical staging according to the 8th edition of AJCC: cT2–3N1–2M0; 5. Achieved complete clinical response (cCR) after neoadjuvant immunochemotherapy, defined as: (1) Lesion diameter 95% reduction in tumor burden, with tumor shrinking to undetectable size or complete disappearance; (4) Resolution of esophageal cancer–related symptoms such as dysphagia; 6. Karnofsky Performance Status (KPS) score >=70; 7. Adequate organ function, meeting the following criteria: (1) Hematology (without blood transfusion within 14 days): a. Hemoglobin >=100 g/L; b. ANC >=1.5 × 10?/L; c. Platelets >=100 × 10?/L; (2) Normal hepatic and renal function; 8. Signed written informed consent prior to participation; 9. Judged by the investigator to be able to comply with the study protocol; 10. Negative pregnancy test at screening for women of childbearing potential; 11. Male patients with fertility potential and female patients of childbearing potential must agree to use effective contraception throughout the study period; 12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Allergy to or history of severe adverse reactions to immunotherapy or chemotherapy drugs, making the patient unable to tolerate such treatments; 2. History of or concurrent malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]; 3. Clear tendency to bleeding or clinically significant hemorrhagic symptoms within 28 days prior to enrollment, including but not limited to gastrointestinal bleeding, epistaxis (excluding minor nasal bleeding or blood-tinged mucus), and persistent bleeding disorders or coagulopathies; 4. History of hematemesis or hemoptysis within 28 days prior to enrollment (defined as vomiting or coughing up >=1 teaspoon of fresh blood or small clots), but patients with blood-streaked sputum may be included; 5. Clinical staging inappropriate for ESD, such as lesions invading extraesophageal tissues or distant metastasis, or failure to achieve at least partial clinical response after neoadjuvant immunochemotherapy; 6. Clear surgical contraindications, such as cardiopulmonary insufficiency, coagulopathy, severe obesity, or other conditions that may increase surgical risk; 7. Unwillingness to comply with the study protocol, such as attending regular follow-up visits or completing treatment cycles; patients with psychiatric disorders that impair comprehension of study information or provision of informed consent; 8. Presence of any of the following serious acute comorbidities before enrollment: (1) Unstable angina and/or congestive heart failure or vascular disease (e.g., aortic aneurysm requiring surgical repair, peripheral venous thrombosis) requiring hospitalization within 12 months, or other cardiac damage (e.g., uncontrolled arrhythmia, myocardial infarction, or ischemia) judged by the investigator as potentially affecting the safety evaluation of study drugs; (2) History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months; (3) Exacerbation of chronic obstructive pulmonary disease (COPD) or other respiratory disease requiring hospitalization within 28 days; (4) Active pulmonary infection and/or acute bacterial or fungal infection requiring intravenous antibiotics within 28 days; (5) Pregnancy or breastfeeding; (6) Grade >=II interstitial pneumonia, Grade >=III hepatic or renal dysfunction, or Grade >=V hematologic abnormalities (hemoglobin, neutrophils, or platelets) at the end of neoadjuvant immunochemotherapy that fail to recover within 2 weeks; 9. Positive virological findings during screening, defined as: (1) HBsAg positive with serum HBV DNA >=1×10³ copies/L; (2) Anti-HCV positive; (3) HIV positive; 10. Participation in another clinical trial of anti-tumor drugs within 28 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS, 3-year OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical Safety;Postoperative recurrence and metastasis;)Quality of Life;Postoperative Esophageal Function Assessment: Swallowing Function, Nutritional Status;Monitoring of Postoperative Recurrence Using MRD; | — |
Countries
China
Contacts
Public ContactKe Jiang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed