Esophageal Adenocarcinoma and Esophagogastric Junction Adenocarcinoma
Conditions
Interventions
ADC plus immunotherapy group:disitamab vedotin, adebrelimab in combination with tegafur-gimeracil-oteracil potassium and oxaliplatin (SOX)
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study, is able to sign the informed consent form, and has good compliance. 2. Aged 18–75 years old (at the time of signing the informed consent form), regardless of gender. 3. Patients with histologically and/or cytologically confirmed esophageal adenocarcinoma and esophagogastric junction adenocarcinoma, diagnosed as locally advanced according to the 8th edition of the UICC/AJCC staging criteria. The cTNM stage is confirmed as cT1-4aN+M0 or cT3-4aN0M0 by endoscopic ultrasonography, enhanced CT/MRI scan, and PET-CT (combined with diagnostic laparoscopy if necessary). The patient agrees to receive radical surgery, and the investigator assesses the lesion as resectable. 4. No prior systemic therapy for the current disease, including anti-tumor radiotherapy/chemotherapy, immunotherapy, etc. 5. HER2 expression confirmed by IHC results of endoscopic biopsy tissue (defined as IHC 1+, 2+, or 3+). 6. ECOG performance status score of 0–1. 7. Able to swallow tablets and capsules normally. 8. Expected survival time >= 6 months. 9. Good function of major organs, meeting the following criteria: (1) Hematological parameters (without blood transfusion or hematopoietic stimulating factor administration for correction within 7 days prior to testing): Hemoglobin (Hb) >= 90 g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet count (PLT) >= 80×10^9/L. (2) Biochemical parameters: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 mL/min. (3)Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) = 50%. (5) Sufficient organ function as clinically determined by the physician. 10. Subjects with reproductive potential must use an appropriate contraceptive method during the study and within 120 days after the end of the study. A negative serum pregnancy test result must be obtained within 7 days prior to study enrollment, and the subject must not be breastfeeding.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Complicated with malignant diseases other than esophageal adenocarcinoma or esophagogastric junction adenocarcinoma (excluding early-stage tumors that have received radical treatment). 2. Tumor lesions with bleeding tendency (e.g., presence of active ulcerative tumor lesions, or judged by the investigator to be at risk of severe gastrointestinal hemorrhage, etc.). 3. Currently participating in an interventional clinical study treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose. 4. A history of receiving the following therapies: anti-HER2 agents, anti-PD-1 agents, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.). 5. A history of active autoimmune diseases requiring systemic therapy (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy. 6. Receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first study dose; Note: The use of physiological doses of glucocorticoids (=10 mg/day of prednisone or equivalent drugs) is permitted. 7. A known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 8. Known hypersensitivity to any drug used in this study. 9. Peripheral neuropathy of grade >=2. 10. A known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies). 11. Subjects with active hepatitis B or hepatitis C (Hepatitis B reference: HBsAg-positive with HBVDNA >=500 IU/ml; Hepatitis C reference: HCV antibody-positive with HCV viral load > upper limit of normal). 12. Having received a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Administration of inactivated seasonal influenza vaccine via injection within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not allowed. 13. Pregnant or lactating women. 14. Presence of any severe or uncontrolled systemic diseases, such as: (1) Significant and poorly controlled symptomatic abnormalities in resting electrocardiogram rhythm, conduction, or morphology, including complete left bundle branch block, atrioventricular block of grade >=?, ventricular arrhythmia, or atrial fibrillation. (2) Unstable angina pectoris, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) class >=2. (3) A history of any arterial thrombosis, embolism, or ischemia (e.g., myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack) within 6 months prior to enrollment. (4) Poorly controlled hypertension despite standard treatment (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg). (5) A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease. (6) Active pulmonary tuberculosis. (7) Presence of active or uncontrolled infections requiring systemic therapy. (8) Presence of clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response , pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological response,MPR;Objective Response Rate,ORR;R0 resection rate;event free survival,EFS;overall survival;safety; | — |
Countries
China
Contacts
Public ContactLi Yin
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed