MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
Recruiting now · Phase 2
Conditions studied: Esophageal Cancer
In brief
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.
Key facts
- Study ID
- NCT06498752
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 102
- Starts
- 2024-07-16
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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.
Where it is running
- Cancer hospital, CAMS — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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