Esophageal squamous cell carcinoma (ESCC)
Conditions
Interventions
Experimental Group:Iparomlimab and Tuvonralimab + Paclitaxel + Carboplatin
Iparomlimab and Tuvonralimab, 5mg/kg, Q3W, intravenous infusion
Paclitaxel, 175mg/m2 D1, Q3W
Carboplatin, AUC5 D1, Q3W
3 cycles.
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, both male and female; 2. Patients with resectable esophageal squamous cell carcinoma confirmed by histopathology or cytology; 3. Patients with a pathological stage of cT1b-cT2N+ or cT3-cT4a with any N status (Nany). 4. ECOG performance status of 0–1; 5. Expected survival =12 weeks; 6. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 7. The function of vital organs must meet the following requirements (no use of any blood components, cell growth factors, white blood cell boosters, platelet boosters, or anemia correction drugs within 14 days prior to the first dose of the study drug): a. Absolute neutrophil count (ANC) >= 1.5 × 10?/L; b. Platelets >= 100 × 10?/L; c. Hemoglobin >= 10 g/dL; d. Serum albumin >= 2.8 g/dL; e. Total bilirubin 60 mL/min; g. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) 50% on echocardiography before the start of treatment; 10. No history of surgical resection; 11. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment, and voluntarily agree to use appropriate contraception during the observation period and for 8 weeks after the last dose of the study drug; for men, they should be surgically sterile or agree to use appropriate contraception during the observation period and for 8 weeks after the last dose of the study drug. 12. Willing and able to undergo follow-up until death, or until the end of the study, or until the study is terminated.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis or infiltration of adjacent tissues or organs, all stages where the primary tumor is unresectable; 2. BMI 10 mg prednisone equivalent) or other immunosuppressants within 2 weeks prior to the first dose of the study drug; (5) Receipt of an anti-tumor vaccine or administration of a live vaccine within 4 weeks prior to the first dose of the study drug; (6) Major surgery or trauma within 4 weeks prior to the first dose of the study drug; 7. Has active autoimmune disease or a history of autoimmune disease, with the exception of vitiligo or childhood asthma/allergy that has resolved and requires no intervention in adulthood; autoimmune hypothyroidism managed with stable doses of thyroid replacement hormone; and type 1 diabetes managed with stable doses of insulin. 8. Has a history of immunodeficiency, including a positive HIV test, or has other acquired or congenital immunodeficiency diseases, or has a history of organ transplantation or allogeneic bone marrow transplantation; 9. Subjects with poorly controlled cardiovascular clinical symptoms or diseases; 10. Occurrence of severe infection (CTCAE grade >2) within 4 weeks prior to the first dose of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging findings indicating active pulmonary inflammation, presence of signs or symptoms of infection within 2 weeks prior to the first dose of the study drug, or need for oral or intravenous antibiotic therapy, excluding prophylactic antibiotic use. 11. History of interstitial lung disease (excluding radiation pneumonitis that did not require corticosteroid treatment), or history of non-infectious pneumonia; 12. Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but who have not received standard treatment; 13. Peripheral neuropathy > NCI Grade II; 14. Subjects deemed unsuitable for enrollment in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Major Pathological Response Rate;Safety;Event-Free Survival (EFS);Objective Response Rate;R0 Resection Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactWenfeng Yang
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed