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To explore the clinical value of dynamic detection of circulating tumor cells(CTCs), circulating tumor DNA(ctDNA) and cell-free DNA(cfDNA) in neoadjuvant chemotherapy and operation of resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Gastric cancer(GC) is one of the common malignant tumors in world, with relatively high incident rate and mortality among the population. Neoadjuvant chemotherapy is often needed before operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. Neoadjuvant chemotherapy should be combined with platinum and fluorouracil, or paclitaxel should be added on the basis of platinum and fluorouracil. The efficacy of neoadjuvant chemotherapy for GC patients is usually evaluated by computer tomography(CT) scans with RECIST 1.1 criteria and the blood level of carcinoembryonic antigen(CEA),CA19-9 (carbohydrate antigen 19-9)and CA72-4(carbohydrate antigen 72-4) tumor markers.
CTC originating from solid tumors are related to hematogenous metastatic spread to distant sites. Therefore, CTC analysis has clinical relevance as a biomarker to noninvasively monitor cancer progression and guide therapy.Moreover, ctDNA is a part of cfDNA derived from apoptotic, necrotic or secreted DNA fragments of tumor cells, ctDNA contains the same genetic defects as the tumor DNA of its origin, such as point mutation and rearrangement. We speculate CTC, ctDNA and cfDNA are new biomarkers for tumor, which can guide neoadjuvant chemotherapy and surgical treatment for patients with locally advanced or resectable gastric or gastro-oesophageal junction cancer.
In this study, investigators will compare the clinical value of the dynamic detection of CTC, ctDNA and cfDNA with CEA ,CA19-9 and CA72-4 tumor markers and CT scan according the RECIST 1.1 criteria in neoadjuvant chemotherapy and operation for resectable or locally advanced gastric or gastro-oesophageal junction cancer. Investigators will also explore the relationship between the dynamic changes of CTC, ctDNA and cfDNA and the prognosis of patients after operation. The results will provide lots of meaningful information which may further improve the treatment of locally advanced or resectable gastric or gastro-oesophageal junction cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving neoadjuvant chemotherapy. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy with PSOX regimen. | Drug | Resectable gastric or gastro-oesophageal junction cancer patients receiving neoadjuvant chemotherapy with PSOX(Paclitaxel+Oxaliplatin+S1)regimen. The details are as follows: Paclitaxel 135mg/m2 d1, Oxaliplatin 85mg/m2 d1, S1 40-60mg/m2 twice daily, d1-14 , 21 days is one cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation. | Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation. | 2 years |
| Types of CTC pre- and post- neoadjuvant chemotherapy and after operation. | Types of CTC pre- and post- neoadjuvant chemotherapy and after operation. | 2 years |
| Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation. | Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation. | 2 years |
| Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation. | Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation. | 2 years |
| The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation. | The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation. | 2 years |
| The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation. | The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival(DFS) | The relationship between CTC, ctDNA and cfDNA and DFS in patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer. | 2 years |
| Overall survival(OS) |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiuda Zhao | Recruiting | Xining | Qinghai | 810000 | China |
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|
| Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma. | Other | Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in 3 time points:Before neoadjuvant chemotherapy, After 2-3 cycles of neoadjuvant chemotherapy, 10 days after operation. |
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| Detect the tumor related DNA in pathological tissues after operation. | Other | Detect the tumor related DNA in pathological tissues after operation. |
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| Follow-up of DFS and OS in patients with gastric cancer after operation. | Other | Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer. |
|
The relationship between CTC, ctDNA and cfDNA and OS in patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer.
| 2 years |
| Types of tumor-associated DNA in tumor tissues after operation. | Types of tumor-associated DNA in tumor tissues after operation. | 2 years |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D000074141 | Circulating Tumor DNA |
| D000073888 | Cell-Free Nucleic Acids |
| D018395 | CA-19-9 Antigen |
| C083825 | CA-72-4 antigen |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004273 | DNA, Neoplasm |
| D004247 | DNA |
| D015295 | Antigens, Tumor-Associated, Carbohydrate |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D007983 | Lewis Blood Group Antigens |
| D001789 | Blood Group Antigens |
| D000954 | Antigens, Surface |
| D000939 | Epitopes |
| D007519 | Isoantigens |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
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