esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Immunotherapy combined with chemotherapy induction therapy for 2+2 cycles (tislelizumab + albumin paclitaxel + cisplatin, Q3W)
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who sign the informed consent form and are willing to complete the study according to the protocol; 2. Pathologically and radiologically confirmed as cT4 and/or cN3 (AJCC 8th edition TNM staging) esophageal squamous cell carcinoma; 3. Aged 18-75 years; 4. ECOG performance status: 0-1; 5. No distant organ metastases, including lung, liver, pelvic, or peritoneal metastases; 6. Patients assessed by CT or endoscopic ultrasound as having unresectable esophageal squamous cell carcinoma; 7. Normal major organ function, including: (1) Hematological tests (no use of any blood components, growth factors, white blood cell stimulants, platelet stimulants, or anemia correction drugs within 14 days prior to the first administration of the investigational drug): White blood cell count = 4.0×10^9/L; Neutrophil count = 1.5×10^9/L; Platelet count = 100×10^9/L; Hemoglobin = 90 g/L; (2) Biochemical tests: Total bilirubin = 1.5×ULN, ALT = 2.5×ULN, AST = 2.5×ULN, serum creatinine = 1.5×ULN or creatinine clearance rate = 50 mL/min (Cockcroft-Gault formula); (3) Coagulation function: International normalized ratio (INR) = 1.5×ULN; Activated partial thromboplastin time (APTT) = 1.5×ULN; (4) Blood glucose: Within normal range and/or diabetic patients under treatment but with stable blood glucose control; 8. Female subjects of childbearing potential must have a negative serum pregnancy test conducted within 72 hours before starting treatment with the investigational drug and must use effective contraception methods during the trial period and for at least three months after the last dose administered (e.g., intrauterine device [IUD], contraceptive pills or condoms); male subjects with partners of childbearing age should also employ effective contraception during the trial period and for three months following their last dose; 9. Subjects must demonstrate good compliance and be able to follow up on efficacy assessments as well as adverse events/reactions in accordance with protocol requirements.
Exclusion criteria
Exclusion criteria: 1. History of allergy to the components of the study drug. 2. Previously received or currently receiving any of the following treatments: 1) Any radiotherapy, chemotherapy, immune checkpoint inhibitors, or other anti-tumor drugs targeting tumors; 2) Use of immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes (dose > prednisone or equivalent dose) within 2 weeks before the first use of the study drug; inhaled or topical steroids and adrenal corticosteroid replacement at doses > prednisone or equivalent dose are allowed in the absence of active autoimmune disease; 3) Received attenuated live vaccines within 4 weeks before the first use of the study drug; 4) Underwent major surgery or had severe trauma within 4 weeks before the first use of the study drug. 3. History of immunodeficiency, including: 1) Positive HIV test; 2) Other acquired or congenital immunodeficiency diseases; 3) History of organ transplantation or allogeneic bone marrow transplantation. 4. Uncontrolled cardiac clinical symptoms or diseases, including but not limited to: 1) NYHA class II or higher heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmias that are not well controlled by clinical intervention. 5. Severe infection (CTCAE 5.0 grade > 2) within 4 weeks before the first use of the study drug, such as: 1) Severe pneumonia, bacteremia, or infection complications requiring hospitalization; 2) Baseline chest imaging indicating active pulmonary inflammation; 3) Symptoms and signs of infection within 14 days before the first use of the study drug or requiring oral or intravenous antibiotics (excluding prophylactic use of intravenous antibiotics for no more than 48 hours). 6. Use of other investigational drugs within 4 weeks before randomization. 7. Currently have interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other lung conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or active pneumonia or severe lung function impairment as shown by screening CT; active tuberculosis. 8. Any active autoimmune disease or history of autoimmune disease with a potential for recurrence, including but not limited to: 1) Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled only by hormone replacement therapy may be enrolled); 2) Patients with skin diseases not requiring systemic treatment, such as vitiligo, psoriasis, alopecia; 3) Type I diabetes controlled by insulin treatment or a history of asthma that has completely resolved in childhood and requires no intervention may be enrolled; 4) Asthma patients requiring intervention with bronchodilators cannot be enrolled. 9. Active hepatitis B (HBV DNA = 2000 IU/mL or 104 copies/mL), hepatitis C (positive hepatitis C antibody, and HCV RNA above the detection limit of the analytical method). 10. Diagnosed with other malignant tumors within 5 years before the first use of the study drug, unless the malignant tumors have a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;MPR;ORR;1-year survival rate;1-year dislease-free survival rate; | — |
Countries
China
Contacts
Public ContactMa Yegang
Liaoning Cancer Hospital & Institute
Outcome results
None listed