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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
For eligible patients with metastatic esophageal squamous cell carcinoma, they will receive a combination of bemosubaiabumab, anlotinib, radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabumab and anlotinib. * BeMosubaiabumab: 1200mg each time, intravenous injection, once every 3 weeks, with 3 weeks as one treatment cycle. * Anlotinib Hydrochloride: 10mg, taken orally before breakfast (the time of taking the medicine each day should be as similar as possible), once a day. Take for 2 weeks, then stop for 1 week. 3 weeks constitute one treatment cycle for 2 treatment cycles; if there is a missed dose during the treatment period, and the time from the missed dose to the next dose is less than 12 hours, no additional dose will be given. The dose can be adjusted to 8mg according to the patient's condition. * Radiotherapy: 50.4 Gy in 28 fractions. ④ Chemotherapy: The researcher will select the chemotherapy regimen based on the specific conditio
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGObjective Response Rate(ORR)
The proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR).
Time frame: one year
Progression Free Survival(PFS)
It refers to the period from the date of the first medication administration to the date of the first occurrence of disease progression or any cause of death, whichever comes first.
Time frame: one year
Disease Control Rate(DCR)
The percentage of cases with complete remission, partial remission and stable disease that have been confirmed among the evaluable efficacy patients
Time frame: one year
Duration of Response(DoR)
The time period from the first assessment of the tumor as being in complete response (CR) or partial response (PR) to the first assessment of the tumor as being in progressive disease (PD) or death due to any cause.
Time frame: one year
Overall Survival
The period from the date of the first medication administration to (due to any cause) death
Time frame: one year
Safety
Safety monitoring (reporting of adverse events or serious adverse events) should be conducted from the time the subjects are enrolled until the end of the study.
Time frame: one year
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