New combo therapy aims to shrink stomach cancer spread
NCT ID NCT07304258
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a treatment plan for people with stomach cancer that has spread to the lining of the abdomen. The plan combines heated chemotherapy directly in the abdomen (HIPEC), standard chemotherapy, and an immunotherapy drug called tislelizumab. The goal is to see if this combination can shrink the cancer enough to allow for complete surgical removal. About 30 adults who have not had prior treatment will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2025
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial; 2. Age between 18 and 75 years; 3. Male or non-pregnant, non-lactating female; 4. Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis; 5. HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1; 6. Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10); 7. No other distant metastases; 8. Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; 9. Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN; 10. Left ventricular ejection fraction ≥50%; 11. ECOG performance status 0-1; 12. Ability to comply with the study protocol and voluntarily provide signed informed consent. Exclusion Criteria: 1. Inability to comply with the study protocol or procedures; 2. Known HER2-positive status; 3. Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types; 4. Current conditions or diseases affecting drug absorption; 5. Patients preoperatively confirmed as unsuitable for conversion therapy; 6. Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension; 7. Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth); 8. Known allergy to the investigational drug(s); 9. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways; 10. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (HBV DNA ≥1×10⁴ copies/mL or \>2000 IU/mL despite prior antiviral therapy); Known primary immunodeficiency or active tuberculosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of human immunodeficiency virus (HIV) infection (HIV antibody positive); 11. Significant malnutrition (weight loss ≥5% within 1 month or \>15% within 3 months prior to informed consent, or food intake reduced by ≥50% within 1 week), unless corrected for ≥4 weeks before the first dose of investigational drug; 12. History of other primary malignancies, except: * Malignancies in complete remission for at least 2 years prior to enrollment with no required treatment during the study; * Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence; * Adequately treated carcinoma in situ with no evidence of recurrence; 13. Female patients who are pregnant or breastfeeding; 14. Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion; 15. Patients deemed ineligible for the study by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gastric adenocarcinoma with peritoneal metastasis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.