Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
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.
Background: Although immune combined chemotherapy has established its position as the first-line standard treatment for locally advanced unresectable or metastatic esophageal cancer, resistance and disease progression inevitably occur in most patients. While earlier studies have shown some therapeutic advantages of the combination of PD-1/PDL1 inhibitors with anti-angiogenic drugs, the efficacy as a second-line treatment remains unsatisfactory, necessitating further exploration of combination therapies such as chemotherapy.We conduct this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur in treating the patients with locally advanced or metastatic esophageal squamous cell carcinoma who has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy. Method: This is a prospective single arm two-stage phase II study, with an intended enrollment of 32 patients. Eligible patients with esophageal squamous cell carcinoma will receive Adebrelimab at a dose of 20mg/kg, on day 1 via intravenous drip every 21 days, in combination with Apatinib at a dose of 250mg orally once daily on days 1-21 every 21 days, and Tegafur orally once daily on days 1-21 every 21 days（BSA<1.25m2,40mg; BSA=1.25～1.5m2,50mg;BSA>1.5m2, 60mg）. Each treatment cycle lasts for 21 days. Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or death. Imaging evaluation for efficacy will be conducted every 6 to 8 weeks (±7 days) after the start of the initial treatment until disease progression, death, initiation of new anticancer therapy, withdrawal of informed consent, loss to follow-up, or study termination. The primary endpoint is objective response rate (ORR), and secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. ;