RecruitingPhase 2NCT06498752

MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer

A Phase II Clinical Trial of Consolidation Therapy Guided by MRD Testing After Radical Radiotherapy for Esophageal Cancer

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

102 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether guiding additional (consolidation) cancer treatment after radiation therapy based on minimal residual disease (MRD) blood tests — which detect tiny amounts of leftover cancer DNA in the bloodstream — can improve survival in patients with esophageal cancer. **You may be eligible if...** - You are 18 or older with confirmed squamous cell carcinoma of the esophagus, clinical stage I–IVa - Your cancer was considered inoperable and you completed radical radiation therapy (50–60 Gy) - You also received chemotherapy with platinum-based drugs (e.g., paclitaxel or 5-FU), with or without a PD-1 immunotherapy drug - Your general health score (ECOG) is ≤ 1 and blood counts/organ function are normal **You may NOT be eligible if...** - You did not complete the required radiation or chemotherapy regimen - Your cancer is a different type (e.g., adenocarcinoma) - You have active autoimmune disease or serious infections - 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPD-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.