An observational study in Esophageal Carcinoma and Minimal Residual Disease, sponsored by Hebei Medical University Fourth Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Hebei Medical University Fourth Hospital · Observational
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.
Presence of circulating tumor DNA (ctDNA) is indicative for minimal residual disease (MRD) and has high predictive value for efficacy and tumor recurrence. Concurrent chemoradiotherapy becomes the standard of care for unresectable, locally advanced esophageal squamous cell cancer, and the addition of immunotherapy to radiotherapy has been shown to increase efficacy without increasing side effects. The ECMRD-001 trial aims to assess changes in 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). The specimen collection time points were divided into MRD-related blood collections, MRD-related tissue collection, T-cell immunohistobank-related blood collections, and T-cell immunohistobank-related tissue collection before, during, and after treatment and follow-up. Primary endpoint is the relationship between MRD status at different time points and treatment efficacy. Secondary endpoints include the relationship between MRD status and immune microenvironment, radiotherapy dose, and tumor recurrence. Exploratory endpoint is to investigate ctDNA mutations in ESCC patients receiving adjuvant immunotherapy. To the investigators' knowledge, the ECMRD-001 study is the first clinical trial to investigate ctDNA-based MRD guided strategies in stage II-III ESCC patients who receive radical chemoradiotherapy combined with immunotherapy after neoadjuvant immunochemotherapy followed by adjuvant immunotherapy. After our research it may be possible to confirm that ctDNA-based MRD may be a predictive marker for the efficacy and tumor recurrence of inoperable ESCC patients; elevated ctDNA-MRD may predict tumor recurrence earlier than imaging; ctDNA-based MRD analysis and ctDNA-based MRD guided diagnosis and treatment may be implemented into clinical practice to improve efficacy and reduce tumor recurrence of inoperable stage II-III ESCC.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 56 is below the median of 200 across 346 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Hebei Medical University Fourth Hospital is the lead sponsor of 81 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Esophageal squamous cell cancer patients who receive radical chemoradiotherapy combined with immunotherapy after neoadjuvant immunochemotherapy followed by adjuvant immunotherapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Time frame: 2023/2/22-2027/12/31
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).
Time frame: 2023/2/22-2027/12/31
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).
Time frame: 2023/2/22-2027/12/31
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.
Time frame: 2023/2/22-2027/12/31
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).
Time frame: 2023/2/22-2027/12/31
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
Time frame: 2023/2/22-2027/12/31
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).
Time frame: 2023/2/22-2027/12/31
Started Feb 2023 (actual). Primary completion is estimated for Dec 2024, 22 months after the start.
Of 125 non-industry observational studies under Esophageal Neoplasms, half reached primary completion within 112 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 318. This study's planned 22 months is below that.
Counting every sponsor, half of 139 studies reached it within 99 months; a quarter within 41 and three quarters within 318.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hebei Medical University Fourth Hospital