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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
102 participants
Jul 16, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- ≥18 years, any gender
- Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is I-VIa (2018 AJCC Cancer Staging Manual, 8th Edition) , primary unresectable oesophageal cancer
- ECOG performance status \<= 1.
- No significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function
- Completed radical radiotherapy (dose 50-60Gy);
- Received a systemic regimen of platinum in combination with paclitaxel or a 5-FU-based two-drug regimen with or without PD-1 monotherapy in accordance with the CSCO guidelines, and S-1 monotherapy in elderly patients;
- Informed consent
Exclusion Criteria5
- Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- Active infection currently exists, serious illness such as myocardial infarction in the 6 months prior to enrolment
- History of autoimmune diseases
- Participate in other clinical trials at present or within 4 weeks before enrollment;
- Received systemic therapy (chemotherapy alone or chemotherapy combined with immunotherapy) for more than 4 cycles.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06498752