Gastric CancerPhase 3NCT05871099
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
A Phase 3 study testing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in people with Gastric Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Xiaodong Liu, MD, 86532-82911324, miaozilxd@163.com
About this study
Official 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
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.
- Conditions
- Gastric Cancer
- Being tested
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- Keywords
- Advanced Gastric Cancer, HIPEC, Laparoscopic Gastrectomy, Randomized Clinical Trial, Recurrence-free survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Procedure or surgery
Experimental group receive HIPEC two times after laproscopic gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles. Receives: Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) |
| Control group | No intervention | Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-years Recurrence-free survival
Measured: 5 years
Secondary outcomes (6)
5-year overall survival rate
Measured: 5 years
peritoneal metastasis rate
Measured: 5 years
peritoneal metastasis-free survival
Measured: 5 years
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
Measured: 5 years
distant metastasis rate
Measured: 5 years
Toxic and side effects of the program
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start20 Nov 2022
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- 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 Airport 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
- Investigators
- Yanbing Zhou, MD, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871099
- Sponsor's protocol ID
- HIPEC-09
- Status last verified
- Mar 2026
- First submitted
- 14 May 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05871099
- Acronym / sponsor ID
- HIPEC-09
- Conditions
- Gastric Cancer
- Keywords
- Advanced Gastric Cancer, HIPEC, Laparoscopic Gastrectomy, Randomized Clinical Trial, Recurrence-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- 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 Airport 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
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles. |
| Control group | No intervention | –Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Experimental group receive HIPEC two times after laproscopic gastrectomy | Procedure or surgery | Experimental group |
Primary outcome
5-years Recurrence-free survival
Time frame: 5 years
6 secondary outcomes
5-year overall survival rate
Time frame: 5 years
peritoneal metastasis rate
Time frame: 5 years
peritoneal metastasis-free survival
Time frame: 5 years
Regional recurrence rate
Time frame: 5 years
distant metastasis rate
Time frame: 5 years
Toxic and side effects of the program
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 41888710Liu 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanbing Zhou, MD study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in people with Gastric Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanbing Zhou, MD (86532-82911324, zhouyanbing@qduhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-years Recurrence-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.