IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

NCT04611997 | Active Not Recruiting Phase 3

• 1 other identifier: FUGES-020
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with locally advanced gastric adenocarcinoma (cT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection ICG group and non-injection ICG group

Conditions

Gastric Cancer; Lymph Node Metastases

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate

  Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.

  3 years

Secondary Outcomes (1)

• Total number of retrieved lymph nodes

  30 days

Study Arms (2)

Group A

EXPERIMENTAL

Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group)

Drug: Indocyanine Green

Group B

PLACEBO COMPARATOR

Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
• No distant metastasis, no invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
• Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
• ASA (American Society of Anesthesiology) score I to III
• Written informed consent

You may not qualify if:

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
• History of previous gastric surgery (including ESD/EMR for gastric cancer)
• Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging.
• Other malignant disease within the past 5 years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• History of continuous systematic administration of corticosteroids within one month
• Requirement for simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• FEV1 (forced expiratory volume in one second)\<50% of predicted values
• Diffuse invasive gastric cancer
• Preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Chang-ming Huang

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Lymphatic Metastasis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group A (Study Group): Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group) Group B (Control Group): Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 2, 2020
• Study Start: November 16, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CN (1)