A Single-arm, Single-center, Exploratory Clinical Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
This study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design. Eligible patients with oligometastatic esophageal squamous cell carcinoma were treated with bemosubaiabant, anlotinib, and combined radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabant and anlotinib. During the study period, the subjects were not allowed to receive any other anti-tumor treatments. If the dose of anlotinib hydrochloride was adjusted due to safety events for the subjects, the anlotinib hydrochloride would be dispensed according to the investigator's prescription.
• Voluntarily participated in this study and signed the informed consent form, with good compliance and cooperation during the follow-up;
• Male or female aged 18 years or above;
• Patients diagnosed with oligometastatic esophageal squamous cell carcinoma through imaging. Oligometastatic esophageal cancer is defined as having no more than 5 metastatic lesions other than the primary tumor at the initial diagnosis or during treatment, and the metastatic lesions involve no more than 2 distant organs, and the disease duration is more than 3 months;
• At least one measurable lesion according to the RECIST 1.1 standard;
• Expected lifespan of at least 3 months;
• ECOG (Eastern Cooperative Oncology Group) score: 0-1 point;
• Adequate organ and bone marrow functions;
• For fertile women, appropriate contraceptive measures must be taken from the screening to 3 months after stopping the study treatment, and must be non-lactating subjects. Before starting the medication, the pregnancy test should be negative. For men, they must agree to use appropriate methods of contraception during the trial and for 8 weeks after the last administration of the trial drug or have undergone surgical sterilization.