to evaluate the efficacy and safety of afatinib for advanced altrk-negative escc

Conditions: Advanced Esophageal Squamous Cell Carcinoma

Summary: this is a phase ii study to evaluate the effectiveness and safety of afininib compared to irinotecan in the 3-gene rna sequencing (altrk) negative advanced esophageal squamous squamous carcinoma.

participants were assigned to either group a or group b at 2:1 randomization (block randomization). group a received afatinib (40 mg orally/day) every 6 weeks; group b received irinotecan (140-180mg/m2 intravenous) every 2 weeks.

Eligibility criteria:
inclusion criteria: 1. agree to participate and sign the informed consent form in writing; 2. age: 18-75 years old; 3. no gender limit; 4. esophageal squamous cell carcinoma diagnosed by pathology; 5. the results of 3-gene rna sequencing (altrk) in tumor tissue were negative; 6. imagingly confirmed unresectable advanced esophageal squamous cell carcinoma; 7. failure of previous platinum-containing regimens and immunotherapy regimens (pd-1/pd-l1 monoclonal antibody); 8. at least one measurable lesion (according to recist1.1 criteria) or non-measurable lesion that can be evaluated, with imaging diagnosis ≤ 21 days from enrollment; 9. estimated survival≥ 3 months; 10. general physical condition (ecog) 0-1; 11. sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥ 9 g/dl, white blood cell ≥ 3.0×10\^9/l, neutrophil ≥1.5×10\^9/l, platelet ≥ 100×10\^9/l; normal liver and kidney function (within 14 days): tbil ≤ 1.5 times the upper limit of normal; alt and ast ≤ 2.5 times the upper limit of normal, and if liver metastases are present, ≤ 5 times the upper limit of normal; creatinine ≤ 1.5 times the upper limit of normal; exclusion criteria: 1. those who are currently receiving other effective programs; 2. patients who have participated in other clinical trials within 4 weeks before enrollment; 3. there is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs; 4. those who have received radiotherapy for measurable lesions; 5. previous anti-egfr monoclonal antibody or egfr-tki treatment; 6. patients with other primary malignant tumors other than esophageal cancer at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 7. clinically significant cardiovascular diseases, such as heart failure (nyha grade iii-iv), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or history of myocardial infarction within the past 1 year; 8. neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastases; 9. active severe clinical infection (grade \>2 nci-ctcae version 5.0) within 14 days prior to enrollment, including active tb; 10. known or reported hiv infection or active hepatitis b or c; 11. uncontrolled systemic diseases, such as poorly controlled diabetes; 12. history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/ct; 13. keratitis, ulcerative keratitis or severe dry eye; 14. known hypersensitivity or anaphylaxis to any component of the investigational drug; 15. pregnancy (determined by serum β-chorionic gonadotropin test) or breastfeeding; 16. the investigator determines that there are abnormal heart or lung or kidney or liver function that is not suitable for the treatment of this study;