Heated chemo cocktail may boost immune attack on stomach cancer
NCT ID NCT07621484
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests a new approach for people with locally advanced stomach cancer that has not spread to other organs. First, patients receive heated chemotherapy directly into the abdomen to kill any hidden cancer cells. Then they get an immunotherapy drug (serplulimab) combined with standard chemo before surgery to remove the tumor. The goal is to see if this combination leads to a complete disappearance of cancer in the removed tissue. About 48 adults will take part in this single-center trial.
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 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2028
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: * Aged 18 to 75 years (inclusive); gender unrestricted. * Histologically confirmed gastric or gastroesophageal junction adenocarcinoma via endoscopic biopsy. * Clinical stage cT3-4a (imaging evidence of tumor invasion into or penetration through the serosa), N+ (lymph node positive), M0 (no distant organ metastasis), based on the 8th Edition of the AJCC Staging Manual. * HER2-negative disease, defined as HER2 IHC 0 or 1+, or IHC 2+ with negative ISH. * Diagnostic laparoscopy confirms the absence of macroscopic peritoneal metastasis (P0) and negative peritoneal lavage cytology (CY0). * Adequate cardiac function, rendering the patient eligible for curative-intent resection. If clinically indicated, patients with underlying ischemic heart disease, valvular heart disease, or other severe cardiac conditions must undergo a preoperative cardiac evaluation by a cardiologist. * ECOG Performance Status (PS) score of 0 or 1 within 7 days prior to enrollment. * Anticipated survival time of ≥ 6 months. * Hepatitis B surface antigen (HBsAg) negative (-) and Hepatitis B core antibody (HBcAb) negative (-). If HBsAg is positive (+) or HBcAb is positive (+), the Hepatitis B virus DNA (HBV-DNA) level must be \< 1000 copies/mL, \< 200 IU/mL, or below the upper limit of normal (ULN) at the study center to be eligible for enrollment. * HCV antibody negative (-). * Major organ function is normal, defined as meeting the following criteria (having not received transfusions of blood products, albumin, recombinant human thrombopoietin, or colony-stimulating factors \[CSF\] within 14 days prior to randomization): Hematologic System Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L Platelets (PLT) ≥ 100×10⁹/L Hemoglobin (Hb) ≥ 90 g/L Liver Function Total Bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Aspartate Aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Alkaline Phosphatase (ALP) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver and/or bone metastases Albumin ≥ 25 g/L Renal Function Creatinine Clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula) Coagulation Function Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN Prothrombin Time (PT) ≤ 1.5×ULN International Normalized Ratio (INR) ≤ 1.5×ULN -Female patients must meet the following criteria: Be in a postmenopausal state (defined as having had no menstruation for at least 1 year, with no other confirmed cause for amenorrhea other than menopause), or have undergone surgical sterilization (removal of ovaries and/or uterus); alternatively, patients with reproductive potential must simultaneously meet the following requirements: * A serum pregnancy test result must be negative within 7 days prior to randomization; * Agree to use a contraceptive method with an annual failure rate of \< 1% or practice abstinence (avoidance of heterosexual intercourse) (from the time of signing the informed consent form until at least 120 days after the last dose of the investigational drug, and at least 6 \[months\] after the last dose of the chemotherapy drug ...months (contraceptive methods with an annual failure rate of \< 1% include bilateral tubal ligation, vasectomy, correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices \[IUDs\], and copper-containing IUDs); * Must not be breastfeeding. -Male patients must meet the following criteria: Agree to practice abstinence (avoid heterosexual intercourse) or use contraception, as specified below: If the partner is a female of childbearing potential or is pregnant, the male patient must practice abstinence or correctly use condoms for contraception-to prevent drug exposure to the embryo-during the chemotherapy treatment period and for at least 6 months after the last dose of chemotherapy medication, and for at least 120 days after the last dose of the investigational drug. The reliability of sexual abstinence should be evaluated with reference to the duration of the clinical study, patient preference, and lifestyle. Periodic abstinence (e.g., calendar-based, ovulation-based, basal body temperature, or post-ovulation methods) and withdrawal (coitus interruptus) are not considered acceptable methods of contraception. Exclusion Criteria: * History of other active malignancies within the past 5 years, or the presence of other active malignancies at the time of enrollment. Patients with cured localized tumors-such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, or carcinoma in situ of the breast-are eligible for enrollment. * Presence of documented distant metastases (e.g., liver, lung, or bone metastases) or laparoscopically confirmed peritoneal seeding (P1). * Patients scheduled to undergo, or with a history of having undergone, organ or bone marrow transplantation. * Occurrence of myocardial infarction or poorly controlled arrhythmias (including a QTc interval ≥ 450 ms for males or ≥ 470 ms for females; QTc interval calculated using the Fridericia formula) within 6 months prior to enrollment. * Presence of NYHA Class III or IV heart failure, or a cardiac ultrasound result showing a Left Ventricular Ejection Fraction (LVEF) \< 50%. * Human Immunodeficiency Virus (HIV) infection. * Presence of active pulmonary tuberculosis. * History of, or current presence of, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe impairment of pulmonary function that could interfere with the detection or management of suspected drug-related pulmonary toxicity. * Presence of a known active or suspected autoimmune disease. Exceptions are made for patients whose disease is in a stable state at the time of enrollment (defined as requiring no systemic immunosuppressive therapy). * Receipt of a live vaccine within 28 days prior to enrollment; inactivated viral vaccines for seasonal influenza are permitted. * Patients requiring systemic corticosteroid therapy (at a prednisone-equivalent dose \> 10 mg/day) or other immunosuppressive medications within 14 days prior to enrollment or during the study period. However, the following exceptions are permitted: in the absence of active autoimmune disease, patients may use topical or inhaled corticosteroids, or receive adrenal replacement therapy at a prednisone-equivalent dose ≤ 10 mg/day. * Presence of any active infection requiring systemic anti-infective treatment within 14 days prior to enrollment; prophylactic antibiotic treatment (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease) is an exception. * Prior receipt of any anti-tumor therapy for the current gastric cancer, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy. * Currently receiving treatment in another clinical study, or the planned start date of the treatment in this study is less than 14 days after the completion of treatment in a previous clinical study. * Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug. * Known history of substance abuse (including drug abuse); patients who have ceased alcohol consumption are eligible for enrollment. * Presence of any condition that may increase the risks associated with study participation or the investigational drug, or presence of other severe, acute, or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the clinical study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gastric adenocarcinoma 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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One small incision vs several: robotic stomach cancer surgery put to the test
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a vaccine stop GI cancers from returning?
- Blood test aims to catch Cancer's return earlier