NCT05626569

Anti-PD-1 Immunotherapy Combined With SBRT for Patients With Oligometastatic ESCC

Phase 2 Study of Anti-PD-1 Immunotherapy Combined With Stereotactic Body Radiation Therapy for Patients With Oligometastatic Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this phase II clinical trial is to explore the efficacy and safety of anti-PD1 combined with stereotactic body radiation therapy (SBRT) for patients with oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4\~6 cycles of systemic chemotherapy and anti-PD-1.

Conditions

• Esophageal Squamous Cell Carcinoma
• Oligometastatic Disease

Interventions

Type	Name	Description
DRUG	PD-1 combined with SBRT	Anti-PD1 monoclonal antibody combined with SBRT. The SBRT defined as the radiation prescription with single dose equal or over 4Gy and the fractions less or equal to 10 fractions. BED equal or over 50Gy is required.

Timeline

• Start date: 2022-12-10
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2022-11-23
• Last updated: 2024-01-03

Locations

1 site across 1 country: China