Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498752
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-20
Brief Title:
MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
A Phase II Clinical Trial of Consolidation Therapy Guided by MRD Testing After Radical Radiotherapy for Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 unresectable locally advanced esophageal cancer and the 5-year survival rate is only about 30 but due to the lack of evidence consolidation therapy has not been explicitly recommended in major guidelines
In the CheckMate 577 study patients who did not achieve pathological complete response pCR after surgery improved their survival through immunology consolidation therapy with PD-1 monotherapy suggesting that patients who did not achieve clinical complete response cCR after radiotherapy may benefit from immunology consolidation therapy This suggests that patients who do not have a clinical complete response cCR after radiotherapy are likely to benefit from immunology consolidation therapy Patients with cCR after radiotherapy may achieve similar results to those achieved with radical surgery and consolidation is probably not necessary
However existing clinical practice is unable to accurately determine the efficacy of radiotherapy in esophageal cancer making risk-of-recurrence-guided stratified consolidation strategies difficult to achieve Most of the ongoing radiotherapy-immunotherapy studies in esophageal cancer have been designed to treat all patients indiscriminately with immunology consolidation therapy which may lead to over-treatment of cCR patients
Therefore there is an urgent need to find easily accessible and reliable biomarkers for the efficacy of radiotherapy in esophageal cancer and to carry out prospective clinical studies as soon as possible so as to optimize the strategy of consolidation therapy after radiotherapy in esophageal cancer The high sensitivity of minimal residual disease MRD detection technology established by the researchers team provides a prerequisite for this
In the CheckMate 577 study patients who did not achieve pathological complete response pCR after surgery improved their survival through immunology consolidation therapy with PD-1 monotherapy suggesting that patients who did not achieve clinical complete response cCR after radiotherapy may benefit from immunology consolidation therapy This suggests that patients who do not have a clinical complete response cCR after radiotherapy are likely to benefit from immunology consolidation therapy Patients with cCR after radiotherapy may achieve similar results to those achieved with radical surgery and consolidation is probably not necessary
However existing clinical practice is unable to accurately determine the efficacy of radiotherapy in esophageal cancer making risk-of-recurrence-guided stratified consolidation strategies difficult to achieve Most of the ongoing radiotherapy-immunotherapy studies in esophageal cancer have been designed to treat all patients indiscriminately with immunology consolidation therapy which may lead to over-treatment of cCR patients
Therefore there is an urgent need to find easily accessible and reliable biomarkers for the efficacy of radiotherapy in esophageal cancer and to carry out prospective clinical studies as soon as possible so as to optimize the strategy of consolidation therapy after radiotherapy in esophageal cancer The high sensitivity of minimal residual disease MRD detection technology established by the researchers team provides a prerequisite for this
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None