Robot-assisted D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate the safety of robot-assisted radical gastrectomy with D2 lymph node dissection in postoperative complications in patients with neoadjuvant chemotherapy for gastric cancer (cT3-4a, N+, M0).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age from over 18 to under 75 years; Primary gastric adenocarcinoma (including pap, tub, muc, sig, and por) confirmed pathologically by endoscopic biopsy; cT3-4a, N-/+, M0 according to the AJCC 8th Cancer Staging Manual; Without peritoneal metastasis (examined by laparoscopic examination); Radical resection (R0) through distal subtotal gastrectomy with D2 lymphadenectomy is anticipated; Performance status 0 or 1 (Eastern Cooperative Oncology Group) ; ASA (American Society of Anesthesiology) score ≤ 3;

• Normal hemodynamic indices:

• Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L; Liver and renal function: BIL\<1.5 times of the upper limit of normal reference values, ALT and AST\<2.5 times of the upper limit of normal reference values, and Crea≤1 time of upper limits of normal reference values.

• Therapeutic response rating after neoadjuvant chemotherapy is CR, PR, SD, or Therapeutic response rating after neoadjuvant chemotherapy is PD, tumor is expected to have radical resection; Subjects are still willing to continue participating in this clinical trial.

Locations
Other Locations
China
Fourth Affiliated Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Time Frame
Start Date: 2023-01-20
Completion Date: 2024-06-20
Participants
Target number of participants: 70
Treatments
Experimental: Robot-assisted D2 distal gastrectomy
Robot-assisted D2 distal gastrectomy after 3-Cycle SOX neoadjuvant chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Hebei Medical University

This content was sourced from clinicaltrials.gov