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NCT Number: NCT05871099

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location status: Recruiting

Location contact

Xiaodong Liu, MD

CONTACT

[email protected]

86532-82911324

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) Newly treated patients who did not receive chemotherapy, radiotherapy or other antitumor therapy before the start of the clinical trial;(2) Aged 18-80 years;(3) male or non-pregnant or lactating female;(4) Gastric adenocarcinoma was pathologically confirmed, and laparoscopic (robotic) radical gastrectomy was planned;(5) Patients with T stage T3 or above, no distant metastasis, and feasible criteria for laparoscopic D2 radical resection (AJCC Eighth edition);(6) The estimated survival time is more than 6 months;(7) History of nonabdominal surgery (except laparoscopic cholecystectomy);(8) The bone marrow reserve function was good, and the blood routine met the following conditions: white blood cell count ≥3.5×109/L, neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L;(9) Organ function was good, and biochemical examination met the following conditions: ALT≤2.5× upper limit of normal value (ULN), AST≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;(10) Functional status: 0-1 (ECOG);(11) Preoperative ASA grade I-III;(12) Voluntarily sign the informed consent.

Exclusion criteria

(1) Lymph node BulkyN2 status was diagnosed by abdominal CT/MRI, that is, at least one lymph node meridian ≥3cm or three consecutive lymph nodes, each meridian ≥1.5cm;(2) pregnant or lactating women;(3) Other malignant tumors within 5 years;(4) Preoperative temperature ≥38℃ or complicated with infectious diseases requiring systematic treatment;(5) serious mental illness;(6) Severe respiratory diseases, FEV1< 50%;(7) Severe liver and kidney dysfunction, liver enzyme elevation more than 2 times the normal value;(8) History of unstable angina pectoris or myocardial infarction within 6 months;(9) History of cerebral infarction or cerebral hemorrhage within 6 months, except old infarct;(10) Systemic glucocorticoid therapy within 1 month;(11) Patients with gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;(12) The patient has participated in or is currently participating in other clinical studies (within 6 months);(13) Laparoscopic exploration, biopsy and cytology confirmed intraperitoneal implantation and metastasis.

Treatment and study plan

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Procedure

Experimental group receive HIPEC two times after laproscopic gastrectomy

Primary outcomes

  1. 5-years Recurrence-free survival

    Time frame: 5 years

Secondary outcomes

  1. 5-year overall survival rate

    Time frame: 5 years

  2. peritoneal metastasis rate

    Time frame: 5 years

  3. peritoneal metastasis-free survival

    Time frame: 5 years

  4. Regional recurrence rate

    Time frame: 5 years

    local recurrence after radical gastrectomy refers to the recurrence of anastomosis, duodenal stump, tumor bed, and residual stomach, including the recurrence of regional lymph nodes

  5. distant metastasis rate

    Time frame: 5 years

  6. Toxic and side effects of the program

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Liu, MD

CONTACT

[email protected]

86532-82911324

Yanbing Zhou, MD

CONTACT

[email protected]

86532-82911324

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Brigham and Women's Hospital
  • Chinese PLA General Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Hebei Medical University Fourth Hospital
  • Jinan Central Hospital
  • Mountain University Cancer Hospital
  • Nanfang Hospital, Southern Medical University
  • Peking University Cancer Hospital & Institute
  • Peking University People's Hospital
  • Qilu Hospital of Shandong University
  • Ruijin Hospital
  • Second Xiangya Hospital of Central South University
  • Shandong Cancer Hospital and Institute
  • Shandong First Medical University
  • The First Affiliated Hospital of Nanchang University
  • Tianjin Cancer Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Weihai Municipal Hospital
  • Yantai Yuhuangding Hospital
  • Zhongnan Hospital
  • Zibo Central Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
May 23, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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