Chemotherapy Effect Clinical Trial
Official title:
Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers: A Prospective Multicenter Trial
Gastric cancer is the third major cancer of global cancer-related death. In China, the early
diagnosis rate of gastric cancer is relatively low, and most patients are with locally
advanced tumor stage. The neoadjuvant chemotherapy (NAC) can bring the survival advantage for
gastric cancer patients with locally advanced tumor stage. The primary goal of NAC is to
control the micrometastasis and/or progression of the primary lesion in order to improve
potential of radical gastrectomy. NAC is recommended for patients with locally advanced stage
(T2-4Nx) according to the latest NCCN Gastric Cancer Guidelines.
Laparoscopy distal gastrectomy (LDG) can achieve a better postoperative short-term recovery
than the traditional open distal gastrectomy (ODG), which can reduce the intraoperative blood
loss and to shorten the postoperative hospital stay. Therefore, Enhanced Recovery After
Surgery program of gastric cancer surgery recommends the use of minimally invasive surgery.
For long-term survival outcomes, there is limited evidence supported that laparoscopic
gastrectomy is comparable open gastrectomy. Therefore, due to the lack of high-quality
prospective clinical trial results, whether advanced tumor is suitable for laparoscopic
surgery is still controversial. Therefore, some multi-center prospective randomized
controlled trials have been carried out, compared safety and long-term survival outcome
between laparoscopic and open gastrectomy in locally advanced gastric cancer patients.
CLASS-01 trials reported that for locally advanced gastric cancers, laparoscopic D2 distal
gastrectomy is safe and feasible.
Patient's surgical tolerance and stress response may be inhibited after the treatment of NAC.
The aim of this trial is to confirm the safety of laparoscopy distal D2 radical gastrectomy
for the treatment of after neoadjuvant chemotherapy gastric cancer patients (cT3-4a, N+, M0)
in terms of postoperative complications.
This is a prospective, multi-centers, open-label, single-arm study, and the aim of this trial is to evaluate the safety of laparoscopic distal D2 radical gastrectomy for the treatment of locally advanced gastric cancer (cT3-4a, N-/+, M0) after neoadjuvant chemotherapy. ;
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