neoadjuvant chemoradiotherapy followed by sequential immunotherapy for thoracic esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer

this is a single-arm, phase ib study. eligibility criteria include histologically confirmed escc and clinical t3-4an0m0 or t2-4an+m0 (ajcc/uicc 8). patients received neoadjuvant radiotherapy (41.4gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/ml/min, qw\*5). then followed by two cycles of tislelizumab (200mg, q3w). the primary endpoint was the pathological complete response (pcr) rate and safety.

Eligibility criteria:
inclusion criteria: * ages 18-75. * histology confirmed thoracic esophageal squamous cell carcinoma. * ecog ps 0 to 1. * resectable or potentially resectable t2-4an0 or t1-4an+ patients (ajcc/uicc clinical staging of esophageal squamous cell carcinoma, 8th edition (ctmn)). * length of esophageal lesions \<8cm. * there were no surgical contraindications. * neutrophil count ≥1.5\*109/l, platelet count ≥10.0\*109/l, hemochrome ≥9g/dl; serum creatinine ≤1.5 times the upper limit of normal value; bilirubin ≤1.5 times the upper limit of normal value, ast, alt, akp≤2.5 times the upper limit of normal value. * bmi acuity 18.5 kg/m2. * informed notification and signed informed consent. exclusion criteria: * cervical esophageal cancer (upper part of the lesion in the cervical esophagus). multifocal esophageal carcinoma, lesion length \>8cm. * trachea and aorta were invaded (annex 5). * hoarseness caused by the tumor. * esophageal fistula. * lymph node metastasis in the neck and periceliac artery (ajcc/uicc 8th edition esophageal/esophagogastric junction region lymph node division 1 and 20). * a history of active autoimmune disorders or syndromes requiring treatment with systemic steroids or immunosuppressants (except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone). * she is on hormonal or immunosuppressive therapy. * he's had an organ transplant. * hiv infection, hepatitis c (hepatitis c antibody positive with hcv-rna above the detection limit of the assay), chronic active hepatitis b (hbv dna≥2×103iu/ml or \>1×104copies/ml). * active tuberculosis, interstitial pneumonia, active infection, poorly controlled diabetes, symptomatic arrhythmia, symptomatic new dysfunction, myocardial infarction, active peptic ulcer, chronic active enteritis within 6 months; affected during pregnancy or lactation. * major surgery in the last three months. * severe diabetes mellitus with poor drug control, symptomatic arrhythmia, symptomatic cardiac insufficiency, myocardial infarction within 6 months, chronic active enteritis, chronic nephritis. qtc acuity 470 ms. * he had a history of malignancy. previously received chemotherapy, radiotherapy, targeted therapy, immunotherapy and other antitumor therapies. * patients with allergic or contraindicated taxa. * live vaccine is administered within 30 days before the first dose of immunotherapy. * refusal or inability to sign up for icf study. * the investigator decided that the patient was not suitable to participate.

Keywords: neoadjuvant chemoradiotherapy tislelizumab