Phase II Clinical Study of Adebrelimab Combined With Apatinib and Tegafur in the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Failed First-line Immunotherapy Combined With Chemotherapy
The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.
• 18-75 years old, both sexes.
• Esophageal squamous cell carcinoma confirmed by histology or cytology with locally advanced unresectable or distant metastasis (according to AJCC 8th edition).
• ECOG PS score of 0 \
• Expected survival ≥3 months.
• Patients who have failed first-line immunotherapy combined with chemotherapy.
• At least one measurable or unmeasurable lesion according to RECIST V1.1 criteria (subjects with intracranial lesions alone were excluded from this study).
• Ability to swallow investigational drugs .
• The functional level of the organ must meet the following requirements. (1) ANC≥1.5×109/L; (2) PLT≥100×109/L; (3) Hb≥90 g/L; (4) Serum albumin ≥30 g/L; (5) TBIL≤1.5×ULN; ALT and AST≤2.5 x ULN; For patients with liver metastases, ALT and AST≤5×ULN; (6) Cr ≤1.5×ULN, or creatinine clearance ≥50mL/min as calculated by the Cockcroft-Gault formula; (7) Patients with urinary protein ≥++ should undergo further 24-hour quantitative detection of urinary protein, and the detection result should be\<1.0g.
• Within 7 days prior to enrollment, women of reproductive age must confirm a negative serum pregnancy test and consent to use effective contraception during the study drug use period and within 2 months after the last dose.
⁃ Subjects voluntarily participate in the study after fully informed consent and sign the informed consent.