NCT03957564|UnknownPhase 2
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Sponsor study identifier
interventional
40
1 country
1
Study Start
May 28, 2019
Actual (reported)Primary Completion
May 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2019
Actual (reported)May 21, 2019
Actual (reported)May 28, 2019
Actual (reported)May 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
1. Compare the monitoring of CTC, ctDNA and cfDNA with the results of CT scan and the blood level of CEA ,CA19-9 and CA72-4 tumor markers to explore the clinical value of dynamic detection of CTC, ctDNA and cfDNA in neoadjuvant chemotherapy and operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. 2. Explore the clinical value of different types of CTC in neoadjuvant chemotherapy and Operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. CTC can be classified into three types: epithelial CTC, mesenchymal CTC, hybrids CTC. 3. Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation. 4. To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation.
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.
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.
Jiuda Zhao
Xining, Qinghai, 810000, China
First Submitted
May 7, 2019
First Posted
May 21, 2019
Study Start
May 28, 2019
Actual (reported)Primary Completion
May 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Disease Free Survival(DFS)
2 years
Overall survival(OS)
2 years
Types of tumor-associated DNA in tumor tissues after operation.
2 years
Detect the tumor related DNA in pathological tissues after operation.
Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer.
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Study Completion
May 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2020
Record last verified: 2020-01
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