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NOT YET RECRUITING
NCT07912606
PHASE2

D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

Some patients with gastric cancer have enlarged para-aortic lymph nodes, also called No. 16 lymph nodes, at diagnosis. After standard chemoimmunotherapy, these lymph nodes may shrink to less than 10 mm on imaging, but it is uncertain whether microscopic cancer remains and whether surgically removing these nodes improves disease control. This single-center randomized exploratory trial will enroll 32 patients whose suspicious No. 16a2 and/or No. 16b1 lymph nodes have regressed to less than 10 mm after 2 to 8 cycles of standard chemoimmunotherapy and who have no disease progression or new distant metastases. Participants will be assigned 1:1 to curative-intent gastrectomy with standard D2 lymphadenectomy either with or without para-aortic lymph node dissection. The main outcome is progression-free survival at 2 years after randomization.

Official title: D2 Lymphadenectomy With Versus Without Para-Aortic Lymph Node Dissection in Gastric Cancer Patients With Radiologic Regression of Para-Aortic Lymph Nodes After Chemoimmunotherapy: A Single-Center Randomized Exploratory Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-11-01

Completion Date

2034-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

PROCEDURE

Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection

Distal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and additional systematic dissection of No. 16a2 from the upper border of the celiac trunk to the lower border of the left renal vein and No. 16b1 from the lower border of the left renal vein to the upper border of the inferior mesenteric artery. Robotic, laparoscopic, or open surgery is permitted.

PROCEDURE

Gastrectomy with standard D2 lymphadenectomy

Distal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and without planned systematic No. 16a2 or No. 16b1 dissection. Robotic, laparoscopic, or open surgery is permitted.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China