Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer (MENCA-GC)
|ClinicalTrials.gov Identifier: NCT03425058|
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 8, 2018
|Condition or disease|
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 cT4a/T4bN+M0, including T4b、Bulky-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 MSS/MSI-L or MMRP tumors when treated with surgery alone.
We will combine dMMR/MSI 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 v1.1 criteria using CT/MRI scan.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Prospective Study of Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy [ Time Frame: November 22, 2017 to December 31, 2018 ]The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy
- The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers(CEA, CA19-9,CA72-4 et al) [ Time Frame: November 22, 2017 to December 31, 2018 ]The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers(CEA, CA19-9,CA72-4 et al)
- Prognostic values of the CTCs,ctDNA and dMMR/MSI testing [ Time Frame: November 22, 2017 to December 31, 2018 ]Prognostic values of the CTCs,ctDNA and dMMR/MSI testing
- The concordance of mutations in tumor tissue and ctDNA [ Time Frame: November 22, 2017 to December 31, 2018 ]The concordance of mutations in tumor tissue and ctDNA
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425058
|Contact: Tao Fu, MD||+8601088196970||Futao916@163.com|
|Contact: Zhaode Bu, MDfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 10000|
|Contact: Fu Tao, MD +8601088196970 Futao916@163.com|
|Contact: Zhaode Bu, MD +8601088196945 email@example.com|
|Study Chair:||Jiafu Ji, MD||Beijing Cancer Hospital|