Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy

NCT06895447 | Recruiting Phase 2

• 1 other identifier: RRG-NAT-LAGC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastric Cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Neoadjuvant treatment efficacy

  2 weeks after surgery

• Postoperative quality of life assessment

  30 days after surgery

• Long-term complications (31 days to 3 years post-surgery)

  3 years post-operative

• Pathological response rate

  2 weeks after surgery

• 3-year survival

  3 years post-operative

Study Arms (1)

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

EXPERIMENTAL

Drug: Pre-operative chemotherapy; Procedure: Robotic radical gastrectomy after neoadjuvant therapy

Interventions

Pre-operative chemotherapy DRUG

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

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

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Nanjing Medical Unviersity

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xu

CONTACT

862568306505; liuhongda@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 26, 2025
• Study Start: November 14, 2024
• Primary Completion: November 14, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

CN (1)