Esophageal squamous cell carcinoma.
Conditions
Interventions
Research group:Iparomlimab and Tuvonralimab Injection (QL1706): 5mg/kg
Albumin-bound Paclitaxel: 125 mg/m2, IV, D1, 8, Q3W
Cisplatin: 75mg/m2, IV, D1, Q3W. Each cycle lasts 3 weeks, with surgery performed after 2 cycles of neoadjuvant therapy. Postoperative QL1706: 5mg/kg, Q3W, for up to 12 months.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital).
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent; 2. Age >= 18 years old, =1.5×10^9/L (1500 /mm3); Platelet (PLT) count >=100×10^9/L (100,000/mm3); Hemoglobin >=90g/L; b) liver: serum total bilirubin (TBil) = 30 mL/min; d) Coagulation function: international normalized ratio (INR) <=1.5, and prothrombin time (PT) or activated partial thromboplastin time (APTT) <=1.5×ULN; j) international normalized ratio (INR) <=1.5; Activated partial thromboplastin time (APTT) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis or infiltration into adjacent tissues/organs, all primary unresectable stages. 2. Recurrent patients; 3. History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose; 4. Symptomatic central nervous system metastasis. Patients who have received treatment for brain metastasis and are deemed stable by the investigator may be considered for this study; 5. Poorly controlled tumor-related pain. For patients requiring analgesic therapy, a stable dose must be achieved before study participation; 6. Clinically symptomatic pleural effusion, ascites, or pericardial effusion (PE) that remains unstable despite symptomatic treatment; 7. Known history of severe anaphylactic response to Artemisia argyi, palolitovorilizumab, its components, or planned chemotherapy drugs; 8. Active or suspected autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Exceptions: Type I diabetes mellitus and hypothyroidism controlled by stable-dose replacement therapy, and skin conditions not requiring systemic treatment (e.g., psoriasis, vitiligo); 9. History of interstitial lung disease (ILD) or drug-induced ILD/pneumonitis; 10. Systemic corticosteroid use (prednisone >10 mg/day or equivalent dose) or other immunosuppressive drugs within 14 days prior to the first study dose; 11. History of immunodeficiency diseases, including acquired/congenital immunodeficiencies, organ transplantation, or allogeneic hematopoietic stem cell transplantation/solid organ transplantation; 12. Live vaccination within 4 weeks prior to the first study dose; 13. Severe cardiovascular/cerebrovascular diseases: a) Poorly controlled hypertension or pulmonary hypertension; b) Unstable angina pectoris or myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months prior to study treatment; c) Chronic heart failure with NYHA class >=2; d) Left ventricular ejection fraction (LVEF) 450 msec (men) or >470 msec (women), complete left bundle branch block, third-degree AV block; f) Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study treatment; 14. Positive HIV antibody test or active hepatitis B/C. Exceptions: a) HBcAb/HBsAg-positive with HBV DNA below the lower limit of detection (negative) or <500 IU/mL, and no clinical evidence of active infection per investigator assessment; b) HCV antibody-positive with HCV RNA below the lower limit of detection (negative); 15. Other active malignancies within 5 years (excluding the studied disease), except potentially curable malignancies (e.g., adequately treated thyroid cancer, cervical carcinoma in situ, basal/squamous cell skin cancer, or ductal carcinoma in situ [DCIS] of breast treated with radical surgery); 16. History of drug abuse with inability to abstain or psychiatric disorders; 17. Pregnant or lactating women; 18. Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR);R0 resection rate;Safety; | — |
Countries
China
Contacts
Public ContactJieyong Tian
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital).
Outcome results
None listed