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RecruitingNCT05871099Updated Mar 6, 2026

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

A Phase 3 interventional study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Gastric Cancer, sponsored by The Affiliated Hospital of Qingdao University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by The Affiliated Hospital of Qingdao University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2022, registered May 2023).
  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
616
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Gastric Cancer

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Keywords

  • Advanced Gastric Cancer
  • HIPEC
  • Laparoscopic Gastrectomy
  • Randomized Clinical Trial
  • Recurrence-free survival
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 616 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
616 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6\~8 cycles.

    Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

  • No intervention
    Control group

    Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles

Interventions

  • ProcedureHyperthermic Intraperitoneal Chemotherapy (HIPEC)

    Experimental group receive HIPEC two times after laproscopic gastrectomy

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What researchers measure

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

    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

    Time frame: 5 years

  5. distant metastasis rate

    Time frame: 5 years

  6. Toxic and side effects of the program

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China
    Recruiting
08

References and documents

Publications

  • Liu X, Tian Y, Cao S, Li Z, Wang Q, Liang H, Cui S, Zhang T, Li Y, Sun X, Hu WQ, Guo P, Tao K, Li T, Li L, Wang J, Zhou Y. Study protocol for hyperthermic intraperitoneal chemotherapy in the treatment of locally advanced gastric cancer after laparoscopic or robotic Gastrectomy with D2 lymphadenectomy: a phase III multicentre prospective randomized controlled clinical trial (HIPEC-09). BMC Cancer. 2026 Mar 26;26(1):570. doi: 10.1186/s12885-026-15899-2. PubMed 41888710 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05871099
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborators
Shandong Cancer Hospital and Institute, Chinese PLA General Hospital, Zibo Central Hospital, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Jinan Central Hospital, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, Nanfang Hospital, Southern Medical University, Shandong First Medical University, The First Affiliated Hospital of Nanchang University, Hebei Medical University Fourth Hospital, Peking University Cancer Hospital & Institute, Peking University People's Hospital, Tianjin Cancer Hospital, First Affiliated Hospital Xi'an Jiaotong University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhongnan Hospital, Brigham and Women's Hospital, Second Xiangya Hospital of Central South University, Weihai Municipal Hospital, Mountain University Cancer Hospital, Ruijin Hospital
Responsible party
Sponsor
First posted
May 23, 2023
Start date
Nov 20, 2022
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Mar 6, 2026

Study contacts

Yanbing Zhou, MD
Contact
zhouyanbing@qduhospital.cn
86532-82911324
Xiaodong Liu, MD
Contact
miaozilxd@163.com
86532-82911324
Yanbing Zhou, MD
study director · The Affiliated Hospital of Qingdao University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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