Esophageal squamous cell carcinoma
Conditions
Interventions
Cohort 1:Patients will receive chemoimmunotherapy concurrently with radiotherapy
Cohort 2:Patients will receive two cycles of chemoimmunotherapy followed by radiotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years, inclusive, regardless of gender; 2.Newly diagnosed, treatment-naïve patients with histologically confirmed ESCC, staged as IVB (cTany Nany M1) ; 3.Have achieved Stable Disease (SD) or Partial Response (PR) after receiving 2 cycles of first-line systemic therapy with an immune checkpoint inhibitor (PD-1 monoclonal antibody) in combination with paclitaxel/albumin-bound paclitaxel plus cisplatin; 4.Assessed by the investigator as eligible to receive radiotherapy after completing the aforementioned 2 cycles of systemic therapy; 5.ECOG Performance Status of 0-2; 6.Adequate organ and bone marrow function (no use of any blood components, cell growth factors, or corrective therapy drugs within 14 days prior to the first dose of study treatment):Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L;Platelet count (PLT) >= 90 x 10^9/L;Hemoglobin (HGB) >= 90 g/L;Serum albumin >= 28 g/L;Total bilirubin (TBIL) = 50 mL/min (calculated using the Cockcroft-Gault formula);Adequate coagulation function, defined as International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) = 12 weeks; 9.Willing and able to provide written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1.History of other malignant tumors; 2.Presence of active infection; history of myocardial infarction, cerebrovascular accident, or gastrointestinal, neurological, or cardiopulmonary surgery within the 6 months prior to enrollment; 3.Active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), including but not limited to these diseases or syndromes; 4.Factors assessed by a radiation oncologist as precluding safe radiotherapy administration, such as a high risk of perforation; 5.History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 6.Female patients who are pregnant or breastfeeding; 7.Other severe medical conditions or complications that may affect the study outcomes, such as uncontrolled diabetes, congestive heart failure, etc; 8.Known hypersensitivity to the study drug(s) or any of their excipients, or a history of severe allergic reactions; 9.Any other condition deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival time,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Overall survival, OS;Quality of Life Score;Safety; | — |
Countries
China
Contacts
Public ContactYongmei Liu
West China Hospital, Sichuan University
Outcome results
None listed