Biomarker Analysis of Anti-PD-1 Antibody Combined With Chemotherapy for Neoadjuvant Treatment of Locally Advanced GC
Study Details
Study Description
Brief Summary
Gastric cancer is one of the most common malignant tumors in China, ranking the fifth highest incidence and third highest mortality worldwide. Currently, surgical resection is the preferred treatment for gastric cancer, while the 5-year survival rate of patients is lower than 25%. Compared with surgical resection, immunotherapy is proved to be able to effectively prolong the survival time of patients. On one hand, with the continuous promotion of immunotherapy drugs, the exploration of neoadjuvant application of immunotherapy in gastric cancer has become a hotspot in recent years. It's also on their way that clinical trials of programmed death receptor-1 (PD-1), programmed death ligand-1 (PD-L1) and other immune checkpoints are carried out. On the other hand, the research found that although the curative effect of immune therapy seems better, the present stage gastric cancer immunotherapy marker researches mainly focused on the late stage of the cancer, with few studies of immune markers of neoadjuvant therapy for gastric carcinoma. Additionally, it's not quite feasible for single biomarkers to predict the immune treatment effect precisely. Therefore, combined with clinicopathology and therapeutic effects, this study is aimed to construct the efficacy prediction model of anti-PD-1 antibody together with chemotherapy for locally advanced gastric cancer, by detecting patients' DNA mutation and RNA expression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PD-1 group Patients who are qualified for receiving anti-PD-1 antibody combined with chemotherapy neoadjuvant therapy |
Other: DNA panel and RNA Sequencing
Including a DNA panel containing 571 cancer-associated genes, and full transcriptome sequencing.
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Outcome Measures
Primary Outcome Measures
- Relative DNA biomarkers [From the initiation date of patients recruited into groups to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
At the DNA level, to identify the biomarkers related to the efficacy of neoadjuvant therapy with PD-1 mab combined with chemotherapy in locally advanced gastric cancer.
- Relative RNA biomarkers [From the initiation date of patients recruited into groups to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
At the RNA level, to identify the biomarkers related to the efficacy of neoadjuvant therapy with PD-1 mab combined with chemotherapy in locally advanced gastric cancer.
- Prediction model for efficacy [From the date of completing collecting data, to the date of death from any cause or the end date of the whole trail, whichever came first, assessed up to 2 years]
A prediction model for the efficacy of PD-1 mab combined with chemotherapy, constructed on the basis of clinical pathology, gene variation, gene expression and other factors.
Secondary Outcome Measures
- Conditions of immune microenvironment [From the initiation date of patients recruited into groups to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
To monitor the changes of immune microenvironment before and after neoadjuvant treatment with PD-1 mab combined with chemotherapy for locally advanced gastric cancer.
- Drug resistance mechanism [From the initiation date of patients recruited into groups to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
To explore the drug resistance mechanism of locally advanced gastric cancer after neoadjuvant therapy with PD-1 mab combined with chemotherapy.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18-80 (including 18 and 80);
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Locally advanced gastric cancer (cT3-4a N+ M0, Stage cIII) diagnosed by guidelin-recommended diagnostic tools at our hospital or other hospitals
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Biopsy histologically confirmed adenocarcinoma
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As assessed by the investigator, patients who are qualified for receiving PD-1 mab combined with chemotherapy neoadjuvant therapy;
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Patients who volunteer to participate in this study and sign the informed consent, with good compliance and cooperation in the acquisition of biological specimens.
Exclusion Criteria:
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Patients whose biological specimens do not meet the detection standards;
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In the judgment of the investigator, the patients with factors that might have caused the study to be terminated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | China | 710000 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Gang Ji -2