New cocktail of drugs and radiation aims to boost stomach cancer treatment before surgery
NCT ID NCT03776487
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This pilot study tests whether giving a combination of two immunotherapy drugs (nivolumab and ipilimumab) along with chemotherapy and radiation therapy before surgery can help treat stomach cancer that can be surgically removed. The study includes 32 participants and primarily looks at safety and side effects. The goal is to see if this approach can shrink tumors and improve outcomes without causing too many severe side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab and ipilimumab (immunotherapy drugs), plus chemotherapy (oxaliplatin, fluorouracil) and radiation therapy
- What this could lead to
- If successful, this combination approach could improve outcomes for patients with resectable gastric cancer by shrinking tumors before surgery and reducing recurrence risk.
- What could go wrong
- This is a small, early-phase pilot study (32 participants) focused on safety, not yet proven to work. Side effects from the combination of immunotherapy, chemo, and radiation may be significant.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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32 people
The number who actually took part.
- Started
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Jan 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Subjects must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. * All subjects must have localized/eligible for surgery gastric cancer (GC) or GEJ carcinoma type III, with negative peritoneal washing. Subjects must have histologically confirmed predominant adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging. * Subject must be previously untreated with systemic treatment (including HER 2 inhibitors) given as primary therapy for advanced or metastatic disease. No prior neoadjuvant chemotherapy, immunotherapy, radiotherapy and/or chemoradiotherapy are permitted. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of treatment initiation). * Platelets \>=100,000/mcL (within 28 days of treatment initiation). * Hemoglobin \>= 9 g/dL or \> 5.6 mmol/L; if patient is not actively bleeding and has hemoglobin of \< 9g/dL, patient can receive blood transfusion to increase hemoglobin to \>= 9g/dL (within 28 days of treatment initiation). * Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCL\]) \> 60 mL/min for subjects with creatinine levels \> 1.5 x institutional ULN (measured via 24-hour urine collection) (within 28 days of treatment initiation). Creatinine clearance should be calculated per institutional standard. * Serum total bilirubin =\< 1.5 X ULN (1.5 mg/dL or 25.65 umol/L) OR direct bilirubin \< ULN for subjects with total bilirubin levels \< 1.5 X ULN. Except patients with Gilbert's disease (\< 3 X ULN) (within 28 days of treatment initiation). * Aspartate aminotransferase AST (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X ULN OR \< 5 X ULN for subjects with liver metastases (within 28 days of treatment initiation). * Albumin \>= 3 mg/dL (within 28 days of treatment initiation). * Prothrombin Time (PT) \< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time PTT is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin Time (aPTT) \< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (within 28 days of treatment initiation). * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of study drug. Women must not be breastfeeding. * Prior to chemotherapy and immunotherapy, WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 5 months after the last dose of study treatment (i.e. 30 days (duration of ovulatory cycle plus the time required for the investigational drug to undergo approximately five half-lives). * Males who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment (i.e. 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five half-lives). In addition, male subjects must be willing to refrain from sperm donation during this time. Exclusion Criteria: * Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). * NOTE: Testing for HIV must be performed at sites where mandated locally. * White blood cell (WBC) \< 2000/uL. * Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g. hepatitis B surface antigen (HBsAg Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if hepatitis C virus- ribonucleic acid \[HCV-RNA\] negative). * History of allergy or hypersensitivity to study drug components. * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. * Patients with serious or uncontrolled medical disorders. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
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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.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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