New drug cocktail shows promise against aggressive stomach cancer
NCT ID NCT04661150
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This study tests whether adding an immunotherapy drug (atezolizumab) to standard chemotherapy and targeted therapy (trastuzumab) can better shrink HER2-positive stomach or gastroesophageal junction cancer before surgery. About 42 adults with advanced but removable tumors will receive either the standard combo or the standard plus atezolizumab. The main goal is to see if the new combination leads to more complete tumor disappearance at the time of surgery.
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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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42 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 75 years
- 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: * Histologically confirmed gastric cancer or adenocarcinoma of GEJ * HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed by local review based on pretreatment endoscopic biopsies. * Clinical stage at presentation: cT3/T4a/T4b, or N+, M0 as determined by AJCC staging system, 8th edition * Availability of pretreatment tumor specimen for biomarker analysis by central lab * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy \>= 12 weeks * Adequate hematologic and end-organ function * For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception during the treatment period and to continue its use for at least i) 5 months after the last dose of atezolizumab, ii) 7 months after the last dose of trastuzumab, or iii) 6 months after the last dose of capecitabine or oxaliplatin, whichever is longer. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: * Stage IV (metastatic) or unresectable gastric/GEJ cancer determined by investigators * Prior systemic therapy for treatment of gastric cancer * History of malignancy other than GC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Cardiopulmonary dysfunction * Dyspnea at rest * Active or history of autoimmune disease or immune deficiency with the following exceptions: (a) Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid-replacement hormone are eligible for the study. (b) Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. (c) Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided allof following conditions are met: (i) Rash must cover \< 10% of body surface area (ii) Disease is well controlled at baseline and requires only low-potency topical corticosteroids (iii) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Active tuberculosis * Patients with active hepatitis B * Patients with active hepatitis C
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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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Beijing Cancer Hospital
Beijing, 100142, China
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First Hospital of China Medical University
Shenyang, 110001, China
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Harbin Medical University Cancer Hospital
Harbin, 150081, China
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Liaoning Provincial Cancer Hospital
Shengyang, 110042, China
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Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjing, 300060, China
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West China Hospital, Sichuan University
Chengdu, 610041, China
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Zhongshan Hospital Fudan University
Shanghai, 200032, China
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Other studies related to the condition(s) this trial covers.
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- Engineered immune cells target two markers on Hard-to-Treat tumors