ESCC
Conditions
Interventions
Experimental Group:The neoadjuvant treatment drug before the operation was evoximab +SKB264. The preoperative treatment lasted for 2 cycles, with 3 weeks as one cycle. On the first day of each treatme
Sponsors
The Second Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)The patient is aged between 18 and 75. 2) The patient was diagnosed with esophageal squamous cell carcinoma through tissue or cytological examination. 3) The AJCC 8th edition staging is at stage II-IVA (T2-4aNxM0; at T2N0M0, the tumor length examined by endoscopy is >= 2cm); The tumor was located below the cervical segment and was >= 5cm away from the cricopharyngeal muscle. Two senior thoracic surgeons unanimously agreed that it was resectable. 4) Complete imaging examinations were conducted, and no distant metastasis was observed. a) Cervical ultrasound and enhanced CT of the chest/abdomen; b) When cervical lymph node metastasis is suspected by clinical or cervical ultrasound, ultrasound-guided lymph node biopsy or PET/CT should be performed. c) When liver metastasis is suspected by CT examination, abdominal plain scan and enhanced MRI examination or PET/CT should be performed for a clear diagnosis. d) If accompanied by systemic pain symptoms, bone scan may be necessary. e) Ultrasound gastroscopy is encouraged to determine the stage. 5) No previous treatment related to tumor diseases (including radiotherapy, chemotherapy, targeted therapy, immunotherapy or traditional Chinese medicine treatment) has been received. 6) The quality of life score was evaluated based on the activity status scoring scale developed by the Eastern Cooperative Oncology Group (ECOG) [1], and patients with an ECOG score of 0-1 were included; 7) There is sufficient organ and bone marrow function, meeting the following definitions: a) blood routine test (no blood transfusion, no use of granulocyte colony-stimulating factor (G-CSF), and no correction with other drugs within 14 days before treatment) b) Neutrophil count (NE) >1500/µL; c) Hemoglobin count (HGB) >8.0 g/dL; d) Platelet count (PLT) > 100,000 /µL; e) Blood biochemistry (liver function) f) Serum creatinine (Cr) <= 2.5× upper limit of normal (ULN); g) Total bilirubin (TBIL) <= 2.5×ULN; h) The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is <= 2.5×ULN; 8) With my consent and the signing of the informed consent form, and in compliance with the planned visit, research treatment, laboratory tests and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1)Patients who have received the following medical interventions within four weeks before treatment: 2) Surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy for tumors; 3) Participate in drug treatment in other clinical studies; 4) History of vaccination with attenuated live vaccines. 5) Previously received anti-programmed death-1 (PD-1) /PD-1 ligand (PD-L1) monoclonal antibody cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immunotherapy or molecular targeted therapy. 6) There is a plan to carry out radiotherapy treatment for esophageal squamous cell carcinoma during the research period; 7) As diagnosed by imaging, there is distant metastasis of the tumor. Cervical ultrasound and enhanced CT of the chest/abdomen suggest metastasis to other organs; Metastasis to other organs confirmed by PET/CT or MRI; 8) Patients with esophageal squamous cell carcinoma complicated with interstitial pneumonia or pulmonary fibrosis; 9) Immunosuppressive drugs or glucocorticoids have been used in the past within 7 days before the start of treatment; 10) There is any active autoimmune disease or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11) Active infection occurred 4 weeks before treatment (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C occurred during screening/before the first administration; 12) Had been diagnosed with any other malignant tumor before treatment. 13) Known to have been allergic to the research drug or any of its excipients, or had a severe allergic reaction to other monoclonal antibodies. 14) Pregnant or lactating women and women of childbearing age have not taken reliable contraceptive measures. According to the researchers' judgment, there are concomitant diseases (such as poorly controlled hypertension, poorly controlled diabetes, poorly controlled neurological or mental disorders, etc.) or any other conditions that seriously endanger the safety of the subjects, may confuse the research results, or affect the subjects' completion of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Countries
China
Contacts
Public ContactXiaolong Yan
The Second Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed