Gastric CancerPhase 2NCT06685887
A Clinical Study Evaluating the Efficacy of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis
A Phase 2 study testing HIPEC, SOX and Immune Checkpoint Inhibitors in people with Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- HIPEC, SOX and Immune Checkpoint Inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to Dec 2027
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years
- Men, or non-pregnant and non-lactating women
- Pathological diagnosis as gastric malignant tumor
- diagnosis of peritoneal metastasis [peritoneal cancer index (PCI) ≤ 12 points] by laparoscopic exploration
- Normal major organ function:
- 1) HB ≥ 90 g/L； ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL<1.5ULN; ALT, AST <2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not receive radiation therapy, chemotherapy, targeted therapy, or immunotherapy.
- 7. Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1 8. Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.
Who cannot join
- Patients have other malignant tumors within the past 5 years.
- Patients use immunosuppressant within 30 days prior to the initial use of tirelizumab, excluding nasal sprays and physiological doses of inhaled corticosteroids or systemic steroids from consideration.
- Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
- Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
- Patients with epilepsy or other mental disorders.
- Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases.
- Pregnant or lactating women.
- Patients with other distant 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
Wuhan Union Hospital
Wuhan, Hubei, 430022
Kaixiong Tao, PhD, 13507155452, taokaixiong@hust.edu.cn
Yuping Yin, PhD, 15927412321, yinyuping2017@hust.edu.cn
About this study
Official title: Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis
This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.
Read the detailed description
Gastric cancer with peritoneal metastasis represents an advanced stage of the disease, with a very poor prognosis for patients. It is crucial to develop more effective treatment options to improve their prognosis. CRS with HIPEC has shown promise in extending survival for these patients. Currently, a PCI value ≥12 is widely recognized as significantly impacting the prognosis of gastric cancer peritoneal metastasis.
Recent clinical trials have resulted in the global endorsement of immune checkpoint inhibitors as a third-line therapy for gastric cancer. In March 2020, the National Medical Products Administration (NMPA) granted approval for nivolumab to be used in advanced or recurrent patients with gastric or esophagogastric junction adenocarcinoma who have received two or more systemic treatments.
However, there remains a lack of widely accepted effective treatment regimens for patients with peritoneal metastasis of gastric cancer. The CSCO recommends that such patients be referred for standard advanced gastric cancer treatments or consider participation in clinical trials. Consequently, our center has developed a comprehensive treatment protocol involving systemic chemotherapy (SOX), immune checkpoint inhibitors (Tislelizumab) and HIPEC, aiming to investigate the safety of this regimen and further enhance the prognosis of patients with peritoneal metastasis from gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- HIPEC, SOX, Immune Checkpoint Inhibitors
- Keywords
- Peritoneal Metastasis, HIPEC, SOX, Tislelizumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECDrug
HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.
SOXDrug
Oxaliplatin, 130 mg, i.v. + S-1 (40 mg per dose for BSA <1.25; 60 mg per dose for BSA 1.25 to 1.5; 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle d1-14, q3w
Immune Checkpoint InhibitorsDrug
Tislelizumab, 200 mg, q3w
| Study group | Role | What they receive |
|---|---|---|
| HIPEC combined with SOX and Tislelizumab | Experimental | The participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group. Receives: Drug: HIPEC; Drug: SOX; Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The proportion of patients who achieved R0 resection
Measured: 1 year
Secondary outcomes (3)
1,2,3-year OS rate
The proportion of patients who will be alive within 1/2/3 years after receiving surgery
Measured: up to 12/24/36-months follow-up
Progression-free Survival
Percentage of all patients who did not experience disease progression or death.
Measured: up to 36-months follow-up
Incidence and severity of adverse reactions and serious adverse events
The incidence of adverse events and serious adverse events (referring to CTCAE 5.0) will be analyzed.
Measured: up to 36-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor
- Investigators
- Kaixiong Tao, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685887
- Sponsor's protocol ID
- UHCT230584
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT06685887
- Acronym / sponsor ID
- UHCT230584
- Conditions
- Gastric Cancer
- Keywords
- Peritoneal Metastasis, HIPEC, SOX, Tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Nov 2024 (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.
This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.
Detailed description
Gastric cancer with peritoneal metastasis represents an advanced stage of the disease, with a very poor prognosis for patients. It is crucial to develop more effective treatment options to improve their prognosis. CRS with HIPEC has shown promise in extending survival for these patients. Currently, a PCI value ≥12 is widely recognized as significantly impacting the prognosis of gastric cancer peritoneal metastasis.
Recent clinical trials have resulted in the global endorsement of immune checkpoint inhibitors as a third-line therapy for gastric cancer. In March 2020, the National Medical Products Administration (NMPA) granted approval for nivolumab to be used in advanced or recurrent patients with gastric or esophagogastric junction adenocarcinoma who have received two or more systemic treatments.
However, there remains a lack of widely accepted effective treatment regimens for patients with peritoneal metastasis of gastric cancer. The CSCO recommends that such patients be referred for standard advanced gastric cancer treatments or consider participation in clinical trials. Consequently, our center has developed a comprehensive treatment protocol involving systemic chemotherapy (SOX), immune checkpoint inhibitors (Tislelizumab) and HIPEC, aiming to investigate the safety of this regimen and further enhance the prognosis of patients with peritoneal metastasis from gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC combined with SOX and Tislelizumab | Experimental | Drug: HIPEC, Drug: SOX, Drug: Immune Checkpoint InhibitorsThe participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years
- Men, or non-pregnant and non-lactating women
- Pathological diagnosis as gastric malignant tumor
- diagnosis of peritoneal metastasis [peritoneal cancer index (PCI) ≤ 12 points] by laparoscopic exploration
- Normal major organ function:
Key exclusion criteria (8 listed)
- Patients have other malignant tumors within the past 5 years.
- Patients use immunosuppressant within 30 days prior to the initial use of tirelizumab, excluding nasal sprays and physiological doses of inhaled corticosteroids or systemic steroids from consideration.
- Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
- Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
- Patients with epilepsy or other mental disorders.
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 |
|---|---|---|
| HIPECHIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery. | Drug | HIPEC combined with SOX and Tislelizumab |
| SOXOxaliplatin, 130 mg, i.v. + S-1 (40 mg per dose for BSA <1.25; 60 mg per dose for BSA 1.25 to 1.5; 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle d1-14, q3w | Drug | HIPEC combined with SOX and Tislelizumab |
| Immune Checkpoint InhibitorsTislelizumab, 200 mg, q3w | Drug | HIPEC combined with SOX and Tislelizumab |
Primary outcome
R0 resection rate
Time frame: 1 year
The proportion of patients who achieved R0 resection
3 secondary outcomes
1,2,3-year OS rate
Time frame: up to 12/24/36-months follow-up
Progression-free Survival
Time frame: up to 36-months follow-up
Incidence and severity of adverse reactions and serious adverse events
Time frame: up to 36-months follow-up
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 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Kaixiong Tao, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HIPEC, SOX and Immune Checkpoint Inhibitors in people with Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 7 inclusion and 8 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 11 Apr 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kaixiong Tao, PhD (13507155452, taokaixiong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.