A Multicenter, Open-label, Randomized, Controlled Phase II Study to Evaluate the Efficacy and Safety of Afatinib Versus Irinotecan as a Second-line and Above Treatment for Advanced ALTRK-negative ESCC
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.
• Agree to participate and sign the informed consent form in writing;
• Age: 18-75 years old;
• No gender limit;
• Esophageal squamous cell carcinoma diagnosed by pathology;
• The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative;
• Imagingly confirmed unresectable advanced esophageal squamous cell carcinoma;
• Failure of previous platinum-containing regimens and immunotherapy regimens (PD-1/PD-L1 monoclonal antibody);
• 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;
• Estimated survival≥ 3 months;
⁃ General Physical Condition (ECOG) 0-1;
⁃ 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;