Stomach cancer drug combo shows promise in new trial
NCT ID NCT04882241
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the drug pembrolizumab to standard chemotherapy helps Chinese adults with stomach or gastroesophageal junction cancer. Participants received the drug combination or a placebo before and after surgery. The goal was to see if the combination improves outcomes like preventing cancer from returning.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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120 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Apr 2025
- 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 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: * Has previously untreated localized gastric or gastroesophageal junction (GEJ) adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease. * Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice. * Is willing to provide tissue from a tumor lesion at baseline and at time of surgery. * Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment. * Has adequate organ function. * Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy. * Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. * Has life expectancy of greater than 6 months. Exclusion Criteria: * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Has an active infection requiring systemic therapy. * Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], tumor necrosis factor receptor superfamily member 4 \[OX-40\], necrosis factor receptor superfamily member 9 \[CD137\]) or has previously participated in a MSD pembrolizumab (MK-3475) clinical study. * Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment. * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded. * Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known history of Hepatitis B or known active Hepatitis C virus infection. * Has a known history of active tuberculosis (TB). * Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. * Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy. * Has had an allogenic tissue/solid organ transplant. * Has received a live vaccine within 30 days prior to the first dose of study treatment.
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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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Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638)
Bengbu, Anhui, 233004, China
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Beijing Cancer Hospital ( Site 0221)
Beijing, Beijing Municipality, 100142, China
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Beijing Friendship Hospital ( Site 0637)
Beijing, Beijing Municipality, 100050, China
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Fourth Hospital of Hebei Medical University ( Site 0633)
Shijiazhuang, Hebei, 050035, China
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Fujian Medical University Union Hospital-1 Bingfanglou-Gastric Surgery Department (Site 0632)
Fuzhou Fujian, Fujian, 350001, China
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Fujian Provincial Cancer Hospital ( Site 0230)
Fuzhou, Fujian, 350014, China
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Henan Cancer Hospital (Site 0227)
Zhengzhou, Henan, 450008, China
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Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0642)
Shanghai, Shanghai Municipality, 200127, China
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Shandong Provincial Hospital-Gastrointestinal Surgery ( Site 0640)
Jinan, Shandong, 250001, China
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Sichuan Cancer hospital
Chengdu, Sichuan, 610041, China
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Sir Run Run Shaw Hospital ( Site 0233)
Hangzhou, Zhejiang, 430030, China
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Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 0647)
Xi'an, Shaanxi, 710038, China
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The Affiliated Hospital of Qingdao University ( Site 0636)
Qingdao, Shandong, 266003, China
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The Affiliated Hospital of Xuzhou Medical College-Oncology ( Site 0645)
Xuzhou, Jiangsu, 221006, China
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The First Affiliated Hospital of Guangzhou Medical University ( Site 0224)
Guangzhou, Guangdong, 510120, China
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The First Affiliated Hospital of Wenzhou Medical University (Site 0652)
Wenzhou, Zhejiang, 32500, China
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The First Affiliated Hospital, Sun Yat-sen University (Site 0635)
Guangzhou, Guangdong, 510080, China
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The First Hospital of Jilin University-Gastrointestinal Surgery ( Site 0234)
Changchun, Jilin, 130021, China
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Zhejiang Cancer Hospital ( Site 0231)
Hangzhou, Zhejiang, 310022, China
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Zhejiang Provincial People's Hospital-Oncology (Site 0656)
Hangzhou, Zhejiang, 310014, China
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Other studies related to the condition(s) this trial covers.
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- Can a direct hit to tumors make immunotherapy work better?