efficacy and safety of tislelizumab and nab-paclitaxel combined with low-dose radiotherapy in patients with stage ivb esophageal squamous cell carcinoma

Conditions: ESCC

Summary: this study is a single-arm, prospective, open-label clinical study to evaluate the safety and efficacy of tislelizumab combined with chemoradiotherapy in first-line treatment of patients with stage ivb esophageal squamous cell carcinoma.

this study is a single-center, prospective, single-arm, open-label study. it will explore the efficacy and safety of tislelizumab combined with nab-paclitaxel in the first-line treatment of stage ivb esophageal squamous cell carcinoma on the basis of low-dose radiotherapy（40gy/20f，5次/w）. to explore new treatment modalities and prolong patient survival.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of esophageal squamous cell carcinoma -diagnosed with stage ivb esophageal squamous cell carcinoma (uicc/ajcc 8th edition tnm staging system) by ct/mri/pet-ct/ect, laboratory examination and pathological examination results; specific: any t, any n, m1; 2. no previous anti-tumor treatment; expected survival period of more than half a year; 3.18-75 years old, ps score 0-1; 4. according to recist1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose; 5. major organ function is normal, that is, the following criteria are met: 6. no active autoimmune disease; 7. no active hepatitis; 8. general conditions or medical complications can tolerate radiotherapy, chemotherapy and immunotherapy; 9. no history of malignant tumor, no previous anti-tumor therapy; 10. for premenopausal or surgically sterilized female patients: consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 11. understand and sign the informed consent form for this study. exclusion criteria: 1. previous antitumor therapy or radiation therapy for any malignant tumor; 2. patients receiving standard treatment; 3. concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 4. has undergone major surgical procedures unrelated to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures; 5. serious heart disease or discomfort, including but not limited to the following: 6. inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption; 7. known history of allergy to the drug components of this regimen; history of immunodeficiency, including positive hiv test, positive hbv/hcv test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period and within 7 months after the last study drug; 9. have serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition that the investigator considers the patient unsuitable for participation in this study.

Keywords: pd-1 rct ⅳb escc 1 line