Status:
RECRUITING
MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Esophageal cancer is one of the most common lethal tumours in the world and accounts for more than 50% of new cases in China. Definitive concurrent chemoradiotherapy is the standard treatment for unre...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06498752
Start Date
July 16 2024
End Date
June 1 2025
Last Update
August 6 2024
Active Locations (1)
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1
Cancer hospital, CAMS
Beijing, Beijing Municipality, China, 100021