Actively Recruiting
Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-07-01
40
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
J
Jiangsu Cancer Institute & Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years, regardless of gender.
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma after neoadjuvant therapy.
- Tumor stage confirmed as cStage III, suitable for curative R0 resection.
- Patient agrees to robotic-assisted radical surgery and has no surgical contraindications.
- Expected survival of at least 6 months.
- Measurable tumor lesions according to RECIST v1.1 criteria.
- Preoperative ECOG performance status of 0 or 1.
- Good cardiac function and ability to undergo curative resection.
- Normal major organ function with specific laboratory criteria.
- Weight at least 40 kg or BMI over 18.5.
- Signed informed consent form.
You will not qualify if you...
- History of or current active malignancies within the past 5 years, except some cured localized tumors.
- History of upper abdominal surgery except laparoscopic cholecystectomy.
- History of gastric resection, EMR, or ESD.
- Need for surgery for other diseases concurrently.
- Emergency surgery due to gastric cancer complications.
- History or preparation for organ or bone marrow transplantation.
- Recent blood transfusion or bleeding disorders.
- Coagulation disorders or use of certain anticoagulants.
- Recent thromboembolic events.
- Recent myocardial infarction or poorly controlled arrhythmias.
- Severe heart failure or low left ventricular ejection fraction.
- Significant pulmonary dysfunction.
- High urinary protein or symptomatic pleural effusion/ascites requiring intervention.
- HIV infection or active pulmonary tuberculosis.
- Chronic non-healing wounds or fractures.
- History of certain lung diseases or severe pulmonary dysfunction.
- Known active or suspected severe autoimmune diseases.
- Use of systemic corticosteroids or immunosuppressive drugs above specified limits.
- Active infections requiring systemic antibiotics.
- Recent live vaccinations.
- Enrollment in other surgery-related clinical trials.
- History of alcoholism, drug abuse, or substance misuse.
- Noncompliance with medical instructions or incomplete data.
- Pregnant or breastfeeding females.
- Other conditions increasing study risks or deemed unsuitable by investigator.
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
X
Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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