MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
NCT06498752 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2024-08-06
Summary
To further validate the performance of the high-sensitivity MRD assay in patients with squamous esophageal cancer who have completed radical radiotherapy; to validate whether MRD-negative patients can maintain a good prognosis under regular follow-up; and to validate whether MRD-positive patients can improve their survival with consolidation therapy with PD-1 monotherapy.
Conditions
- Esophageal Cancer
Interventions
- DRUG
-
PD-1 monoclonal antibody consolidation therapy
PD-1 monoclonal antibody-based consolidation therapy for 1 year after completion of radiotherapy (or combination chemotherapy up to 4 cycles if less than 4 cycles of chemotherapy). Specific dosing: PD-1 monoclonal antibody, 200mg every 3 weeks.
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
collaborator OTHER -
Hebei Medical University Fourth Hospital
collaborator OTHER -
Tianjin Medical University Cancer Institute and Hospital
collaborator OTHER -
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-16
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
Countries
- China
Study Locations
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