Esophageal cancer
Conditions
Interventions
Experimental group:Srulimab combined with albumin paclitaxel and cisplatin for preoperative neoadjuvant therapy in resectable esophageal squamous cell carcinoma patients.
Sponsors
Zhangzhou Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients enrolled in the study must meet all of the following conditions: 1) Capable of providing written informed consent and understanding and agreeing to comply with the study requirements and schedule of assessments. 2) At least 18 years of age (or the legal age of consent within the jurisdiction where the study is conducted) at the time of signing the informed consent form. 3) Histologically confirmed esophageal squamous cell carcinoma. 4) Pathologically confirmed locally advanced resectable (cT3N1M0/T1-3N2M0) esophageal squamous cell carcinoma (AJCC 8th). a. Assessed to be potentially R0 resection-eligible prior to treatment. b. Treatment-naïve patients at initial diagnosis. 5) Measurable disease present as per RECIST 1.1 criteria. 6) ECOG PS score of 0 or 1. 7) Expected survival time >= 12 weeks. 8) Patients must have good organ function, with screening laboratory values obtained within = 1.5 x 10^9/L, platelets >=75 x 10^9/L, hemoglobin >= 9 g/dL or >= 5.6 mmol/L; b. Serum creatinine = 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula; c. Serum total bilirubin =120 days after the last administration of study drug, with a negative urine or serum pregnancy test result within =120 days after the last administration of study drug. a. A male is defined as sterilized if, prior to enrollment, his semen sample has been examined and found to be free of sperm, which is definitive evidence of male sterility. b. For the purposes of this study, males with known low sperm counts (meeting the definition of subfertility") are not considered infertile.
Exclusion criteria
Exclusion criteria: 1) History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drug that targets T cell co-stimulation or checkpoint pathways. 2) Patients with active autoimmune diseases or a history of autoimmune diseases who may experience recurrence. Note: Patients with the following conditions may be further screened without being excluded: a. Well-controlled type 1 diabetes; b. Hypothyroidism (only requiring hormone replacement therapy for control); c. Well-controlled celiac disease; d. Skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease in remission and not likely to recur without external triggers. 3) Active malignancy within 10 mg/d of prednisone or equivalent dose of other glucocorticoids) or other immunosuppressants. Note: Patients currently using or previously used any of the following steroid regimens may be enrolled: a. Adrenal replacement steroids (prednisone = Grade 3 hypoalbuminemia, or laboratory test abnormalities of potassium, sodium, or corrected calcium > Grade 1 despite standard therapy within 500 IU/mL (or > 2500 copies/mL) in chronic HBV carriers at screening. Note: Non-active hepatitis B surface antigen (HBsAg) carriers and treated and stable hepatitis B patients (HBV DNA 2 weeks before enrollment. 9) Patients with active hepatitis C virus infection. Note: Patients who are HCV antibody negative at screening or HCV antibody positive at screening but subsequently HCV RNA negative may be included. HCV RNA testing will only be performed on patients who are HCV antibody positive. Patients receiving antiviral therapy at screening should be treated for > 2 weeks before enrollmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 Resection Rate;Major pathological remission rate;1 year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactGuoyi Shen
Zhangzhou Hospital Affiliated to Fujian Medical University
Outcome results
None listed