Patients with resectable locally advanced esophageal squamous cell carcinoma
Conditions
Interventions
Experimental Group B:QL1706
Control Group D:Radiotherapy and chemotherapy (using standard radiotherapy scheme)
Experimental Group C:Ql1706 combined with chemotherapy, albumin paclitaxel, 260 mg/m^2, IV, D1, q3w, 3 cycles
Carboplatin, AUC=5,IV,D1,Q3W, 3 cycles
Experimental Group A:Ql1706 combined with chemotherapy, albumin paclitaxel, 260 mg/m ^ 2, IV, D1, q3w, 1 cycle
Carboplatin, AUC=5,IV,D1,Q3W, 1 cycle.
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Aged between 18 and 75 years, regardless of gender; 2: Histologically or cytologically diagnosed locally advanced esophageal squamous cell carcinoma, classified as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition clinical staging; 3: Clinically assessed as resectable or potentially resectable esophageal cancer; 4: Contrast-enhanced CT of the neck shows no suspicious metastatic lymph nodes. Imaging studies indicate no systemic metastasis; 5: No prior anticancer treatments, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc; 6: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7: At least one measurable lesion according to RECIST 1.1 criteria; 8: Preoperative assessment of organ function reveals no surgical contraindications; 9: Adequate organ and bone marrow function, with laboratory test results within 14 days prior to screening meeting the following criteria: (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) White blood cell count (WBC) >= lower limit of normal (LLN); (3) Platelet count (PLT) >= 100 × 10^9/L; (4) Hemoglobin (Hgb) >= 90 g/L; (5) Total bilirubin (TBIL) = 30 g/L. 10: Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment; men and women of childbearing potential must agree to use reliable contraception with their partners throughout the study period. 11: Ability to comply with the study protocol and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1: History of malignancies other than esophageal cancer within the past 5 years (excluding cured local tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate); patients with prostate cancer who have received hormonal therapy and achieved disease-free survival (DFS) for more than 5 years are not excluded; 2: Patients with a high risk of bleeding, including those with a history of gastrointestinal bleeding within the past 6 months, those with coagulation disorders at the time of screening, or those undergoing thrombolytic or anticoagulant therapy; 3: Severe cardiovascular and cerebrovascular diseases: (1) New York Heart Association (NYHA) Class II or above congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular events within 12 months prior to enrollment; (2) Left ventricular ejection fraction (LVEF) 480 ms (calculated using Fridericia's method; if QTc is abnormal, three consecutive tests at 2-minute intervals should be performed, and the average value taken); (3) Poorly controlled hypertension (systolic blood pressure >=150 mmHg and/or diastolic blood pressure >=100 mmHg prior to enrollment, calculated based on the average of >=2 measurements); history of hypertensive crisis or hypertensive encephalopathy; 4: History of interstitial lung disease or pneumonia requiring steroid treatment; 5: Active tuberculosis or anti-tuberculosis treatment within 1 year prior to enrollment; 6: Asthma requiring intermittent use of bronchodilators or other medical interventions; 7: Patients with infectious diseases requiring systemic treatment (oral or intravenous) within 4 weeks prior to enrollment; patients with active hepatitis must receive effective treatment prior to enrollment; 8: Presence of severe unhealed wounds, active ulcers, or untreated fractures; 9: Concurrent conditions that preclude surgery; 10: Previous surgeries that prevent the use of the stomach for esophageal reconstruction in this procedure; 11: Systemic steroid therapy (prednisone >=10 mg daily or equivalent) or other immunosuppressive agents within 2 weeks prior to enrollment; 12: Severe allergy to chemotherapy drugs (albumin-bound paclitaxel or cisplatin); 13: Known allergy to iparomlimab and tuvonralimab (QL1706) or its excipients, or history of allergy, hypersensitivity, or intolerance to other monoclonal antibodies; 14: Active autoimmune disease requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive agents) within the past 2 years; however, replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment and is allowed for enrollment; 15: History of organ transplantation; 16: For patients with HBsAg (+) and/or HBcAb (+), HBV DNA must be 10³ copies/mL should be excluded; 18: Co-infecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Event-Free Survival;Safety;Major Pathological Response;R0 Resection Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactShaolei Li
Peking University Cancer Hospital
Outcome results
None listed