esophageal cancer
Conditions
Interventions
Platinum containing group:Combination therapy of Tislelizumab, albumin paclitaxel, and cisplatin
Platinum without group:Treatment with Tislelizumab+Albumin Paclitaxel without Combination with Cisplatin
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years; 2.Pathologically confirmed esophageal squamous cell carcinoma; 3.Clinical stage cT1b-cT2 N+ M0 or cT3-cT4a any N M0; 4.ECOG Performance Status 0-1; 5.No prior radiotherapy, chemotherapy, or surgery for esophageal cancer; 6.Planned for surgery after neoadjuvant therapy; 7.No significant organ dysfunction; 8.Patients of childbearing potential must use contraception until 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Uncontrolled pleural/pericardial effusion or ascites; 2.BMI <18.5 kg/m² (unless deemed eligible by the investigator after nutritional support); 3.Allergy to any component of the investigational drug; 4.Prior antitumor therapy (including radiotherapy, chemotherapy, or immunotherapy) or use of immunosuppressants within 2 weeks (except for corticosteroids <10 mg/day prednisone equivalent); 5.Active autoimmune disease (except for conditions such as psoriasis or childhood asthma that are in remission); 6.HIV positive or history of immunodeficiency; 7.Severe organ dysfunction assessed by a specialist as incompatible with chemotherapy and surgery; 8.Pregnancy or lactation; 9.Other high-risk factors as judged by the investigator (e.g., psychiatric disorders, alcohol abuse).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary pathological response rate;R0 resection rate;Objective response rate;Progression-free survival;The safety endpoint encompasses chemotherapy- and immune-related adverse events;Surgical complications (anastomotic leakage, pneumonia grading);Quality of life score (EORTC QLQ-C30 scale); | — |
Countries
China
Contacts
Public ContactLai Fancai
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed