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

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).

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancers
• Intervention / Treatment: Drug: Pre-operative chemotherapy; Procedure: Robotic radical gastrectomy after neoadjuvant therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: XU; Phone Number: 862568306505; Email: liuhongda@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • First Affiliated Hospital of Nanjing Medical Unviersity
      • Contact: Hao Xu; Phone Number: 86-2568306505; Email: liuhongda@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 80 years, regardless of gender.
• Histologically confirmed gastric cancer or gastroesophageal junction (GEJ) cancer that has received neoadjuvant therapy, with pathology confirming it is predominantly adenocarcinoma. For GEJ cancer, only Siewert Type III and Siewert Type II cases that do not require combined thoracotomy are eligible.
• Tumor stage confirmed as cStage III, suitable for curative R0 resection, as determined by an evaluation by a gastrointestinal surgeon and a radiologic technician prior to enrollment. The patient agrees to undergo robotic-assisted radical surgery, and the surgeon judges there are no surgical contraindications.
• Expected survival of ≥6 months.
• Measurable tumor lesions as defined by RECIST v1.1 criteria (see Attachment 1).
• Preoperative ECOG performance status score (see Attachment 2) of 0 or 1.
• Good cardiac function, capable of undergoing a curative resection. If there are clinical indications, patients with underlying ischemic, valvular heart disease, or other serious heart conditions should undergo preoperative assessment by a cardiologist.
• Normal major organ function, with the following laboratory criteria:
• Absolute neutrophil count (ANC) ≥ 1.2 x 10^9/L in the absence of granulocyte colony-stimulating factor use within the past 14 days.
• Platelet count ≥ 100 x 10^9/L in the absence of blood transfusion within the past 14 days.
• Hemoglobin > 8 g/dL in the absence of blood transfusion or erythropoietin use within the past 14 days.
• Total bilirubin ≤ 1.5 × the upper limit of normal (ULN); if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN, inclusion is permitted.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
• Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min.
• Coagulation function defined by international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
• Normal thyroid function, defined by thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, patients with normal total T3 (or FT3) and FT4 levels may still be eligible.
• Normal range for myocardial enzyme profile (patients with isolated laboratory abnormalities deemed clinically insignificant by the investigator may still be included).
• Thyroid function tests (TSH, FT3/FT4) within normal limits or with minor clinically insignificant abnormalities.
• Weight ≥ 40 kg (inclusive) or BMI > 18.5.
• The participant has read, understood, and signed the informed consent form.

Exclusion Criteria:

• Patients with a history of (within the past 5 years) or current active malignancies. However, patients with cured localized tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, stage I colorectal cancer, etc., are eligible.
• A history of upper abdominal surgery (except for laparoscopic cholecystectomy).
• A history of gastric resection, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD).
• Patients requiring surgery for other diseases concurrently.
• Emergency surgery performed due to complications of gastric cancer (e.g., bleeding, obstruction, or perforation).
• Patients preparing for or with a history of organ or bone marrow transplantation.
• Blood transfusion within 2 weeks prior to surgery or a history of bleeding disorders, or any severe bleeding event (grade 3 or above according to CTCAE 4.0) occurring within 4 weeks prior to surgery.
• Coagulation disorders or bleeding tendencies (INR > 1.5 without anticoagulant use); patients receiving anticoagulants or vitamin K antagonists, such as warfarin, heparin, or similar agents. Low-dose warfarin (1 mg oral daily) or low-dose aspirin (≤100 mg daily) may be allowed for preventive purposes, provided the prothrombin time international normalized ratio (INR) is ≤ 1.5.
• History of thromboembolic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening. Patients with venous thrombosis caused by prior chemotherapy and deemed healed by the investigator are excluded.
• Myocardial infarction, poorly controlled arrhythmias (including QTc interval > 450 ms for males and > 470 ms for females) within 6 months prior to surgery. QTc interval should be calculated using the Fridericia formula.
• NYHA class III or IV heart failure, or left ventricular ejection fraction (LVEF) < 50% as per echocardiogram.
• Pulmonary dysfunction with FEV1 < 50% of predicted value.
• Urinary protein ≥++ on routine urinalysis, confirmed by 24-hour urinary protein quantification > 1.0 g.
• Clinically symptomatic pleural effusion or ascites requiring clinical intervention.
• Human immunodeficiency virus (HIV) infection.
• Active pulmonary tuberculosis.
• Chronic non-healing wounds or fractures with incomplete healing.
• History of interstitial lung disease, pneumoconiosis, radiation-induced pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction that may interfere with the detection or management of potential drug-related pulmonary toxicity.
• Known active or suspected autoimmune diseases, except those in stable condition at enrollment and without the need for systemic immunosuppressive therapy.
• Severe chronic autoimmune diseases, such as systemic lupus erythematosus, inflammatory bowel diseases (e.g., ulcerative colitis, Crohn's disease), chronic diarrhea syndromes (e.g., irritable bowel syndrome), sarcoidosis, or tuberculosis. Active hepatitis B or C or HIV infections. Non-severe autoimmune conditions, such as controlled psoriasis, dermatitis, or arthritis, are eligible. Patients with hepatitis B virus (HBV) with a viral load < 500 copies/ml may be included.
• Patients who require systemic corticosteroid treatment (> 10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to surgery or during the study period. However, the following are allowed for inclusion: patients without active autoimmune diseases may use topical or inhaled steroids or adrenal hormone replacement therapy with a dose ≤ 10 mg/day prednisone equivalent.
• Patients who have an active infection requiring systemic antibiotic treatment within 14 days prior to surgery (excluding those receiving prophylactic antibiotics for conditions like urinary tract infections or chronic obstructive pulmonary disease).
• Patients who have received live vaccines within 28 days prior to surgery; seasonal influenza vaccination with inactivated viral vaccines is excluded.
• Patients currently enrolled in another clinical trial involving surgery-related treatments.
• Patients with a history of alcoholism, drug abuse, or substance misuse. Patients who have stopped drinking alcohol are eligible.
• Patients who do not comply with medical instructions, fail to follow prescribed medication regimens, or have incomplete data that could impact the assessment of efficacy or safety.
• Pregnant or breastfeeding female patients.
• Patients with conditions that may increase the risks of participating in the study or with other severe, acute, or chronic diseases deemed by the investigator to be unsuitable for participation.
• Other situations determined by the investigator that make the patient unsuitable for this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radical gastrectomy in patients with locally advanced gastric cancer after neoadjuvant therapy

Drug: Pre-operative chemotherapy; Patients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted).; Procedure: Robotic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Jiangsu Cancer Institute & Hospital; The Affiliated Hospital of Xuzhou Medical University; Affiliated Hospital of Nanjing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): November 14, 2025
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: RRG-NAT-LAGC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No