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| Name | Class |
|---|---|
| Jiangsu Cancer Institute & Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
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This study is a prospective, open-label, single-arm phase II clinical trial designed to evaluate the safety and efficacy of robotic radical gastrectomy in patients with locally advanced gastric adenocarcinoma after undergoing neoadjuvant therapy. Conducted at multiple centers, the study aims to include 40 patients confirmed via histopathological and/or cytological analysis. Eligible participants must have stage III resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma based on imaging studies such as ultrasound endoscopy, CT, or MRI.
Patients will receive 3-4 cycles of neoadjuvant therapy, followed by imaging evaluations to assess the treatment response and determine eligibility for radical D2 gastrectomy. Within 2-6 weeks of the final neoadjuvant treatment cycle, eligible patients will undergo robotic radical gastrectomy. Key outcomes include post-surgical complications, pathological responses (pCR, MPR, TRG), and objective response rates (ORR), alongside disease-free survival (DFS) and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative chemotherapy | Drug | Patients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted). |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety and clinical efficacy of robotic radical gastrectomy following neoadjuvant therapy | Early Postoperative Complications: Complications occurring within 30 days post-surgery (number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Neoadjuvant treatment efficacy | R0 resection rate after neoadjuvant therapy | 2 weeks after surgery |
| Postoperative quality of life assessment | Postoperative quality of life assessment (Physicians Global Assessment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu | Contact | 862568306505 | liuhongda@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical Unviersity | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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| Robotic radical gastrectomy after neoadjuvant therapy | Procedure | Eligible participants must have stage III resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma based on imaging studies such as ultrasound endoscopy, CT, or MRI. Patients will receive 3-4 cycles of neoadjuvant therapy, followed by imaging evaluations to assess the treatment response and determine eligibility for radical D2 gastrectomy. Within 2-6 weeks of the final neoadjuvant treatment cycle, eligible patients will undergo robotic radical gastrectomy. |
|
| 30 days after surgery |
| Long-term complications (31 days to 3 years post-surgery) | Long-term complications (31 days to 3 years post-surgery) | 3 years post-operative |
| Pathological response rate | Include pathological complete response (pCR) rate, major pathological response (MPR) rate after neoadjuvant therapy, tumor regression grade (TRG) after neoadjuvant therapy, clinical downstaging rate (T and/or N downstaging) after neoadjuvant therapy, objective response rate (ORR) and disease control rate (DCR) after neoadjuvant therapy (RECIST v1.1) | 2 weeks after surgery |
| 3-year survival | 3-year disease-free survival (DFS) rate 3-year overall survival (OS) rate Patterns of recurrence | 3 years post-operative |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |