Esophagus carcinoma
Conditions
Interventions
immunotherapy combined with low-dose chemotherapy : albumin-bound paclitaxel 182 mg/m2 day 1, cisplatin 53 mg/m2 day 1, and tislelizumab 200mg day 3.
immunotherapy combined with standard-dose chemotherapy: albumin-bound paclitaxel 260mg/m2 day 1, cisplatin 75 mg/m2 day 1, and tislelizumab 200mg day 3.
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Histopathologically or cytologically confirmed esophageal squamous cell carcinoma. (2) Confirmed as thoracic esophageal cancer by computed tomography, magnetic resonance imaging, and endoscopic ultrasonography, with TNM staging (8th edition of the Union for International Cancer Control) of T1b-3N1-3M0 or T3N0M0. (3) Age between 18 and 80 years old. (4) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1. (5) No prior anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery. (6) No contraindications to undergoing surgery. (7) Normal function of major organs, including hematology, blood biochemistry, and coagulation function, without other serious concomitant diseases. (8) Provide written informed consent and volunteer to participate in the study.
Exclusion criteria
Exclusion criteria: (1)Age 80 years old. (2) Concurrent presence of other malignancies. (3) History of intra-abdominal surgery, thoracic surgery, or esophageal surgery. (4) Use of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppressive purposes within 2 weeks before the first dose of the study drug. (5) undergoing major surgery or experiencing serious trauma within 4 weeks before the first dose of the study drug (6) Any active or past autoimmune disease, including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc., severe infectious diseases, or other serious underlying disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathological response;R0 resection rate;objective response rate;disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactXu Li
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed