Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425058
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2018-02-01
Brief Title:
Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Prospective Study of Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2022-08
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:
MENCA-GC
Brief Summary:
Gastric cancer GC is a leading global health problem and is the third most common cause of cancer related death Neoadjuvant chemoradiotherapy nCRT followed by surgery is the mainstay treatment for locally advanced gastric cancer and variable degrees of tumor regression are observed after nCRT Treatment strategies including close surveillance without immediate surgery have been investigated to spare patients with complete tumor regression from potentially adverse outcomes of radical surgery However clinical and radiological assessment of treatment response does not deliver an ideal accuracy of patients identification with complete response In the present study we focused on the clinical courses of patients who have developed locally advanced gastric cancer and investigated the potential clinical utility of the detection of deficient MMRdMMR microsatellite instabilityMSI status and the decreasing level of circulating tumor cells CTCs and circulating tumor DNA ctDNA as promising biomarkers for the diagnosis and prediction of GC during treatment progress Twenty milliliters of plasma were collected at 3 time points before nCRT after 2 cycles of nCRT and after surgery Firefly ctDNA NGS assays were used to track ctDNA mutations previously characterized in paired tumor tissue by massively parallel sequencing MPS We investigated whether circulating tumor DNA ctDNA detection can reflect tumor response to nCRT and detect minimal residual diseaseMRD after surgery We compared CTC and ctDNA levels to clinical radiological and pathological assessment modalities for nCRT response The results will provide lots of information which may contribute to promote the treatment of GC patients We want to introduce these strategies into clinical practice if possible
Detailed Description:
This study is a single-center observational study on a patient cohort of at least 80 patients with histologically-confirmed locally advanced gastric cancer LAGC The protocol used in this study is approved by the Ethics Committee of Beijing Cancer Hospital
The primary endpoint is the 3-year progression-free survival PFS rate The secondary endpoints are the overall survival OS and safety
Currently the best treatment for early and mid-stage LAGC patients is resection but even with successful treatment most patients still relapse and the 5-year survival rate is less than 30
For patients with cT4aT4bNM0 including T4bBulky-N2 primary lesions are not always fully excised during treatment and prognosis for these patients is generally poor Recent studies however have suggested that the inclusion of neoadjuvant chemotherapy NCT can improve patient outcomes by 1 downstaging tumors and increasing the likelihood of curative resection 2 reducing the prevalence of micro metastases
Historically Oxaliplatin and s-1 combination therapy has been shown to be well-tolerated in patients with recurrent or metastatic gastric cancer
To best evaluate the treatment response of NCT we plan to investigate the effect of new technologies and assays on the successful prediction of patient outcomes
Circulating tumor DNA ctDNA fragmented DNA with an average size of 166 bp is released by cancer cells into circulation Circulating tumor cells CTCs are rare malignant cells detached from tumors which enter the bloodstream Both these biomarkers can be used for prognosis and the dynamic monitoring of disease progression
In the MAGIC trial patients with tumor that are MSI-H or MMRD had survival rates superior to those with MSSMSI-L or MMRP tumors when treated with surgery alone
We will combine dMMRMSI status with the dynamic evaluation of CTCs and ctDNA using liquid biopsy technology to determine whether changes in tumor burden in response to NTC can identify potential treatment responders
Sequential peripheral blood samples for CTCs and ctDNA analysis will be taken before and after NCT as well as one week after surgery
Tumor assessments will be performed after 2 cycles NCT based on RECIST v11 criteria using CTMRI scan
The primary endpoint is the 3-year progression-free survival PFS rate The secondary endpoints are the overall survival OS and safety
Currently the best treatment for early and mid-stage LAGC patients is resection but even with successful treatment most patients still relapse and the 5-year survival rate is less than 30
For patients with cT4aT4bNM0 including T4bBulky-N2 primary lesions are not always fully excised during treatment and prognosis for these patients is generally poor Recent studies however have suggested that the inclusion of neoadjuvant chemotherapy NCT can improve patient outcomes by 1 downstaging tumors and increasing the likelihood of curative resection 2 reducing the prevalence of micro metastases
Historically Oxaliplatin and s-1 combination therapy has been shown to be well-tolerated in patients with recurrent or metastatic gastric cancer
To best evaluate the treatment response of NCT we plan to investigate the effect of new technologies and assays on the successful prediction of patient outcomes
Circulating tumor DNA ctDNA fragmented DNA with an average size of 166 bp is released by cancer cells into circulation Circulating tumor cells CTCs are rare malignant cells detached from tumors which enter the bloodstream Both these biomarkers can be used for prognosis and the dynamic monitoring of disease progression
In the MAGIC trial patients with tumor that are MSI-H or MMRD had survival rates superior to those with MSSMSI-L or MMRP tumors when treated with surgery alone
We will combine dMMRMSI status with the dynamic evaluation of CTCs and ctDNA using liquid biopsy technology to determine whether changes in tumor burden in response to NTC can identify potential treatment responders
Sequential peripheral blood samples for CTCs and ctDNA analysis will be taken before and after NCT as well as one week after surgery
Tumor assessments will be performed after 2 cycles NCT based on RECIST v11 criteria using CTMRI scan
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