NCT07455019

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	The 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

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: China