Anti-PD-1 Immunotherapy Combined With SBRT for Patients With Oligometastatic ESCC
NCT05626569 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-01-03
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
- 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.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Mian Xi, MD · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-12-10
- Primary Completion
- 2025-01-01
- Completion
- 2026-01-01
Countries
- China
Study Locations
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