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MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
RECRUITINGPhase 2Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Actively Recruiting
PhasePhase 2
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2024-07-16
Est. completion2025-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06498752
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
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: 1. ≥18 years, any gender 2. 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 3. ECOG performance status \<= 1. 4. No significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function 5. Completed radical radiotherapy (dose 50-60Gy); 6. 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; 7. Informed consent Exclusion Criteria: 1. Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ. 2. Active infection currently exists, serious illness such as myocardial infarction in the 6 months prior to enrolment 3. History of autoimmune diseases 4. Participate in other clinical trials at present or within 4 weeks before enrollment; 5. Received systemic therapy (chemotherapy alone or chemotherapy combined with immunotherapy) for more than 4 cycles.
Conditions2
CancerEsophageal Cancer
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Actively Recruiting
PhasePhase 2
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2024-07-16
Est. completion2025-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06498752