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 ~ 1.
Expected survival ≥3 months.
Have been diagnosed with other malignancies within 5 years, excluding: curable carcinoma in situ of the cervix, skin basal cell carcinoma or squamous cell carcinoma, or any other tumor that has been cured .
Patients who had previously received treament of Adebrelimab, Apatinib or Tegafur.
The following conditions occurred in the previous treatment history. (1)Used Chinese medicine anti-tumor treatment within 2 weeks; (2)Received other anti-tumor therapy within 4 weeks, including but not limited to chemotherapy, radiotherapy, and targeted therapy.
Have not recovered from adverse events caused by prior antitumor therapy (i.e., ≤ grade 1 or at baseline).
Single group
Adebrelimab
Drug20mg/kg ivgtt D1 Q3W
Apatinib
Drug250mg PO QD
Tegafur
Drugdosing based on body surface area：BSA\<1.25m2,40mg; BSA=1.25～1.5m2,50mg; BSA\>1.5m2, 60mg，PO QD D1-21 Q3W
Objective response rate (ORR)
ORR is determined as the percentage of patients who had complete response (CR) or partial response (PR) as best overall response per RECIST v1.1.
Progression-free survival (PFS)
PFS is determined as the duration from the start of treatment until disease progression or death from any cause, whichever occurs first.
Overall survival (OS)
OS is determined as the time from treatment to death.
≥Grade 3 AEs
The total incidence of grade 3 or greater adverse events was included.
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