RecruitingPhase 3NCT05871099

Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not

Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After Laparoscopic Gastrectomy With D2 Lymphadenectomy: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial

Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

616 participants

Start Date

Nov 20, 2022

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

Summary

The goal of this clinical trial is to learn about Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer after Laparoscopic Gastrectomy with D2 Lymphadenectomy. The main question it aims to answer is: whether HIPEC can effectively improving the 5-year overall survival rate and decrease the peritoneal metastases rate of patients with advanced gastric cancer underwent Laparoscopic Gastrectomy with D2 Lymphadenectomy. Participants will be divided into two groups, Experimental group received laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6\~8 cycles; and Control group received laparoscopic (robotic) D2 surgery plus systemic chemotherapy 6\~8 cycles.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing laparoscopic (keyhole) stomach cancer surgery with and without HIPEC — a procedure where heated chemotherapy is circulated inside the abdomen directly after surgery — to see if HIPEC reduces the chance of cancer spreading to the lining of the abdomen (peritoneal metastasis). **You may be eligible if...** - You are between 18 and 80 years old - You have stomach (gastric) adenocarcinoma confirmed by pathology, with tumour stage T3 or above, and no distant spread - You have not received any prior chemotherapy, radiotherapy, or cancer surgery for this diagnosis - You are considered suitable for keyhole radical stomach surgery - Your expected survival is more than 6 months **You may NOT be eligible if...** - Your cancer has already spread to distant organs - You have received prior treatment for this stomach cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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