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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05952661
Other study ID # ECMRD-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 22, 2023
Est. completion date December 31, 2027

Study information

Verified date June 2023
Source Hebei Medical University Fourth Hospital
Contact Wenbin Shen, PhD
Phone +86 15831183879
Email wbshen1979@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial aims to assess changes in minimal residual disease (MRD) status before and after radical concurrent chemoradiotherapy combined with immunotherapy and adjuvant immunotherapy after neoadjuvant immunochemotherapy in patients with inoperable stage II-III esophageal squamous cell cancer (ESCC), and correlate with the efficacy of adjuvant immunotherapy.


Description:

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Study Design


Locations

Country Name City State
China Fourth Hospital of Hebei Medical University Shijiazhuang Hebei

Sponsors (1)

Lead Sponsor Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other ctDNA mutation profiles in ESCC patients undergoing adjuvant immunotherapy. High-frequency mutated genes in the ESCC patients undergoing adjuvant immunotherapy and the corresponding mutation frequency (percentage of samples with mutations out of all samples). 2023/2/22-2027/12/31
Primary Correlations of minimal residual disease (MRD) and efficacy The changes in MRD status before and after radical CCRT combined with immunotherapy and adjuvant immunochemotherapy in patients with inoperable resectable stage II-III ESCC, correlating with the efficacy of adjuvant immunotherapy 2023/2/22-2027/12/31
Secondary The differences in the efficacy of neoadjuvant immunochemotherapy in patients with positive versus negative blood MRD prior to radical concurrent chemoradiotherapy (CCRT) combined with immunotherapy following neoadjuvant immunochemotherapy Differences in overall survival (OS) and progression-free survival (PFS) between MRD positive and negative patients after neoadjuvant immunochemotherapy. OS is defined as time from start of treatment to death (from any cause). PFS is defined as the time between the start of treatment and the onset of (any aspect of) tumor progression or death (from any cause). 2023/2/22-2027/12/31
Secondary The differences in the immune microenvironment in patients with different efficacy responses after radical CCRT combined with immunotherapy MRD status and T-lymphocyte differences across efficacy responses after receiving radical CCRT combined with immunotherapy. Therapeutic response is evaluated according to immune-related response evaluation criteria in solid tumors (irRECIST). 2023/2/22-2027/12/31
Secondary The differences in MRD status between radiation doses of 50Gy and 60Gy, and the correlation with patient prognosis The differences in MRD status between radiation doses of 50Gy and 60Gy, and the correlation with patient prognosis. 2023/2/22-2027/12/31
Secondary The association between serial changes in MRD status and the efficacy of adjuvant immunotherapy The association between serial changes in MRD status and the efficacy of adjuvant immunotherapy. Therapeutic response is evaluated according to immune-related response evaluation criteria in solid tumors (irRECIST). 2023/2/22-2027/12/31
Secondary The timing of MRD advance warning of recurrence in patients ahead of imaging cues The timing of MRD advance warning of recurrence in patients ahead of imaging cues 2023/2/22-2027/12/31
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