Gastric CancerPhase 2NCT04107077
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
A Phase 2 study testing Cisplatin and Mitomycin in people with Gastric Cancer and Peritoneal Carcinomatosis, run by University of Chicago at 1 site in United States.
Trial summary
To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Peritoneal Carcinomatosis
- What is being tested?
- Cisplatin and Mitomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to 20 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed GC/PM only and/or positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of HIPEC for GC/PM in patients under 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must have adequate organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
Show all 19Show fewer
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- creatinine ≤ institutional ULN OR
- glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B).
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Expected survival greater than 3 months.
- Because cisplatin and Mitomycin C are pregnancy category D and potentially teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the study.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years.
- Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain).
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and Mitomycin C.
- Patients with uncontrolled intercurrent illness.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because cisplatin and Mitomycin C are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin and Mitomycin C, breastfeeding should be discontinued if the mother is treated with cisplatin and Mitomycin C.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Cancer Clinical Trials Office, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ardaman Shergill, MD
About this study
Official title: A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases
To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Being tested
- Cisplatin, Mitomycin
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 200mg of Cisplatin
MitomycinDrug
Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 30mg of Mitomycin C.
| Study group | Role | What they receive |
|---|---|---|
| Drug Administration Period | Experimental | Not described Receives: Drug: Cisplatin; Drug: Mitomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PD-L1 expression can be upregulated after administration of HIPEC with greater frequency
To examine if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone. PD-L1 expression will be measured quantitatively by combined positive score (CPS), with upregulation defined as an quantitative increase in PD-L1 expression via CPS compared to the previously measured timepoint (baseline CPS of 0).
Measured: 2 years
Secondary outcomes (5)
The rate of conversion to resectability with repeated interval laparoscopic HIPEC
To examine the rate of conversion to resectability with repeated interval laparoscopic HIPEC as defined by the Phase II trial published by Badgwell et al.
Measured: 2 years
To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.
To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.
Measured: 2 years
Overall Survival Rate
To examine overall survival from diagnosis of metastatic disease. Given the potential for longer survival with repeated interval laparoscopic HIPEC compared to systemic chemotherapy alone, this metric will be assessed. In addition, in (+)PD-L1 patients, survival data in this population undergoing repeated interval laparoscopic HIPEC and systemic PD-1 inhibition is unknown.
Measured: 2 years
Perioperative morbidity at 30 days
To assess perioperative morbidity at 30 days.
Measured: 30 days
Perioperative mortality at 30 days
To assess perioperative mortality at 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start9 Sep 2025
- Primary completion20 Aug 2026
- Study completion20 Dec 2026 (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 University of ChicagoThe 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ardaman Shergill, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107077
- Sponsor's protocol ID
- IRB19-0160
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2019
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT04107077
- Acronym / sponsor ID
- IRB19-0160
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 27 Sep 2019 (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.
To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Administration Period | Experimental | Drug: Cisplatin, Drug: Mitomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with histologically confirmed GC/PM only and/or positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of HIPEC for GC/PM in patients under 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must have adequate organ and marrow function as defined below:
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Key exclusion criteria (8 listed)
- Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years.
- Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain).
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and Mitomycin C.
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 |
|---|---|---|
| CisplatinLaparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 200mg of Cisplatin | Drug | Drug Administration Period |
| MitomycinLaparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 30mg of Mitomycin C. | Drug | Drug Administration Period |
Primary outcome
The PD-L1 expression can be upregulated after administration of HIPEC with greater frequency
Time frame: 2 years
To examine if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone. PD-L1 expression will be measured quantitatively by combined positive score (CPS), with upregulation defined as an quantitative increase in PD-L1 expression via CPS compared to the previously measured timepoint (baseline CPS of 0).
5 secondary outcomes
The rate of conversion to resectability with repeated interval laparoscopic HIPEC
Time frame: 2 years
To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.
Time frame: 2 years
Overall Survival Rate
Time frame: 2 years
Perioperative morbidity at 30 days
Time frame: 30 days
Perioperative mortality at 30 days
Time frame: 30 days
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 8 Sep 2026.
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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.
Ardaman Shergill principal investigator
University of Chicago
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 Cisplatin and Mitomycin in people with Gastric Cancer and Peritoneal Carcinomatosis, run by University of Chicago at 1 site in United States.
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 19 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 8 Sep 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 United States. 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 Cancer Clinical Trials Office (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PD-L1 expression can be upregulated after administration of HIPEC with greater frequency (time frame: 2 years). 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 8 Sep 2026.