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Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

NCT03425058 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-08-09

No results posted yet for this study

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 MMR(dMMR), microsatellite instability(MSI) 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 disease(MRD) 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.

Conditions

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Jiafu Ji, MD · Peking University Cancer Hospital & Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2020-02-01
Completion
2021-10-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425058 on ClinicalTrials.gov