Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental arm :Immune-modulating radiotherapy + Iparomlimab and Tuvonralimab+ albumin - paclitaxel + platinum - based chemotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years, regardless of gender; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma; 3. Clinical staging assessed by CT/MRI/EUS as cT1b-cT2N+/cT3-cT4a any N for thoracic esophageal cancer or esophagogastric junction cancer that is suspicious for involvement of surrounding organs but not confirmed as cT4b any N; 4. Expected to achieve R0 resection; 5. No prior anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; 6. Planned to undergo surgical treatment after neoadjuvant therapy; 7. No contraindications to surgery; 8. Quality of life score evaluated according to the Eastern Cooperative Oncology Group (ECOG) performance status scale , with inclusion of patients with ECOG score 0-1; 9. Adequate organ and marrow function, defined as follows: a) Hematology (no blood products, hematopoietic growth factors, leukocyte-boosting agents, platelet-boosting agents, or anemia-correcting agents allowed within 14 days before the first administration of the study drug) i. Neutrophil count (NE) > 1.5×10^9/L; ii. Hemoglobin count (HGB) > 90 g/L; iii. Platelet count (PLT) > 100×10^9/L; b) Liver and renal function i. Total bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula); c) Coagulation function i. International normalized ratio (INR) <= 1.5×ULN; ii. Activated partial thromboplastin time (APTT) <= 1.5×ULN; 10. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours before the first administration of the study drug and must use effective contraception (such as intrauterine device, oral contraceptives, or condoms) during the trial and for at least 3 months after the last dose; male subjects with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose; 11. The patient has provided written informed consent and agrees to comply with the planned visits, study treatments, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1. Tumors with obvious invasion into adjacent organs of the esophageal lesion (major arteries or trachea); 2. Presence of supraclavicular lymph node metastasis; 3. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage; 4. Poor nutritional status, with a BMI 10 mg/day prednisone or equivalent); in the absence of active autoimmune disease, the use of inhaled or topical corticosteroids and adrenal corticosteroid replacement with a dose >10 mg/day prednisone or equivalent is permitted; c) Live attenuated vaccine within 4 weeks before the first administration of the study drug; d) Major surgery or severe trauma within 4 weeks before the first administration of the study drug; 7. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for enrollment after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have completely resolved without any intervention in adulthood may be considered for enrollment, but those requiring bronchodilator medical intervention are not eligible; 8. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplant or allogeneic bone marrow transplant; 9. Presence of 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 with clinical intervention; 10. Severe infection (CTCAE > Grade 2) within 4 weeks before the first administration of the study drug, such as severe pneumonia requiring hospitalization, sepsis, infectious complications, etc.; baseline chest imaging showing active pulmonary inflammation, presence of signs and symptoms of infection within 14 days before the first administration of the study drug, or need for oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics; 11. Active pulmonary tuberculosis infection identified by history or CT scan, or history of active pulmonary tuberculosis infection within 1 year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago but not properly treated; 12. Active hepatitis B (HBV DNA = 2000 IU/mL or 10^4 copies/mL), hepatitis C (positive hepatitis C antibody and HCV RNA above the lower limit of detection of the assay); 13. Diagnosis of other malignancies within 5 years before the first administration of the study drug, unless the malignancy has a low risk of metastasis or death (5-year survival rate > 90%), such as ade
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) ; Clinical complete response rate (cCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response(MPR) ;R0 Resection Rate ;Disease-Free Survival ;Overall Survival ;Safety ;Objective response rate ;Event-Free Survival (EFS) ; | — |
Countries
China
Contacts
Public ContactWang Xiaohua
Jiangsu Cancer Hospital
Outcome results
None listed