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RecruitingPhase 2NCT06895447

Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy

Efficacy and Safety of Robotic Radical Gastrectomy in Patients With Locally Advanced Gastric Cancer After Neoadjuvant Therapy

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

40 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric Cancers

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing robotic-assisted surgery to traditional open or laparoscopic (keyhole) surgery for removing stomach tumors in patients who have already received chemotherapy before their operation. Researchers want to find out whether robotic surgery leads to better outcomes, fewer complications, and faster recovery for patients with locally advanced stomach or stomach-esophagus junction cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with stomach cancer or stomach-esophagus junction cancer confirmed by biopsy - You have already received pre-surgery (neoadjuvant) chemotherapy - Your cancer stage (confirmed by imaging) makes surgery a viable option - You are healthy enough to undergo major surgery **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You have had previous major stomach surgery - You have serious heart, lung, or other organ problems that would make surgery unsafe - You require a combined chest and abdominal operation (thoracotomy) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPre-operative chemotherapy

Patients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted).

PROCEDURERobotic radical gastrectomy after neoadjuvant therapy

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.

Locations(1)

First Affiliated Hospital of Nanjing Medical Unviersity

Nanjing, Jiangsu, China

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