resectable locally advanced esophageal
Conditions
Interventions
Neoadjuvant Therapy Group:Neoadjuvant Chemoradiotherapy Combined with Immunotherapy
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years old; 2.Histopathological diagnosis of esophageal squamous cell carcinoma; 3.Clinical staging T1-2N1-3M0 or T3NanyM0 (AJCC, 8th Edition, 2017), with the upper boundary of the tumor at least 5 cm from the esophageal entrance, scheduled for neoadjuvant therapy before esophageal cancer surgery; 4.No prior chemotherapy, immunotherapy, targeted therapy, or other anti-tumor related treatments; 5.valuated and included based on the Eastern Cooperative Oncology Group (ECOG) performance status score, with a score of 0-1; 6.Adequate organ function:Complete blood count (within 14 days before treatment without blood transfusion, use of granulocyte colony-stimulating factor (G-CSF), or other medications for correction) Neutrophil count (NE) > 3.5 × 10^9/L Hemoglobin count (HGB) > 90 g/L Platelet count (PLT) > 100 × 10^9/L; Blood biochemistry (liver and kidney function) Serum creatinine (Cr) <= 1.5 × upper limit of normal (ULN) Total bilirubin (TBIL) <= 1.5 × ULN Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels <= 2 × ULN; 7.Ability to comply with the protocol during the study period; 8.Signed informed consent form for participation in this clinical trial;
Exclusion criteria
Exclusion criteria: 1.Patients who have received the following medical interventions within four weeks prior to treatment: participation in drug therapy of other clinical studies; history of attenuated live vaccine inoculation; 2.Patients who have previously received anti-Programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, or other immune or molecular targeted therapies; 3.Patients who are completely unable to eat; 4.Patients with existing tracheoesophageal fistula, deep esophageal ulcers, esophageal perforation, or evidence of hematemesis; 5.Patients judged by the investigator to be unable to tolerate surgery; 6.Patients with interstitial pneumonia, non-infectious pneumonia, or pulmonary fibrosis; 7.Patients who have used immunosuppressive drugs or corticosteroids within 7 days before starting treatment; 8.Patients with any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9.Patients with active infection before treatment (such as requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever >38.5°C during screening/prior to first dose; 10.Patients previously diagnosed with any other malignancies prior to treatment, except for curable skin cancer (non-melanoma), cervical carcinoma in situ, etc; 11.Patients known to be allergic to the study drug or any of its excipients, or who have had severe allergic reactions to other monoclonal antibodies; 12.Pregnant or lactating women and women of childbearing potential who have not taken reliable contraceptive measures; 13.Radiation therapy dose limits that do not meet the limit requirements set by this study; 14.Patients who, in the judgment of the investigator, have comorbidities that seriously endanger the safety of the subject, may confuse the study results, or affect the subject's completion of the study; 15.Patients who are unable to understand the test requirements or are likely to not comply with the test requirements;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Event-free survival rate;Overall survival;R0 Resection Rate;Major Pathological Response Rate; | — |
Countries
China
Contacts
Public ContactYan Luo
Chongqing University Cancer Hospital
Outcome results
None listed