RecruitingPhase 2NCT07455019

A Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer

A Single-arm, Single-center, Exploratory Clinical Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

28 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of an immunotherapy drug (bemosubaiabimab), a targeted anti-cancer drug (anlotinib), and standard chemotherapy plus radiation for patients with esophageal squamous cell cancer (a type of cancer of the food pipe) that has spread to a limited number of other organs—called oligometastatic disease. **You may be eligible if...** - You are 18 or older with confirmed esophageal squamous cell cancer - Your cancer has spread to no more than 5 spots in no more than 2 distant organs (oligometastatic), and has been present for at least 3 months - You have not previously received immunotherapy or anti-angiogenic drugs - You have not received any anti-cancer treatment in the past 4 weeks - You are in good physical condition (ECOG score 0–1) - You have adequate organ function **You may NOT be eligible if...** - You have previously received immunotherapy, bevacizumab, or similar anti-angiogenic drugs - You have received organ transplantation - You have uncontrolled high blood pressure, significant heart disease, active infection, liver disease, kidney failure, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThe treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy

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