Evidence map›Paper›PMID 40610007›Full record

Trial reportCancer research and treatment2026

Nivolumab Plus Chemotherapy versus Placebo Plus Chemotherapy in Korean Patients with HER2-Negative, Untreated, Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer: Subgroup Analysis of a Randomized, Multicenter, Double-Blind Phase 3 Trial (ATTRACTION-4).

Yoon-Koo Kang, Min-Hee Ryu, Do-Youn Oh, Sang Cheul Oh, Sun Young Rha, Keun-Wook Lee, Ik Joo Chung, Sung Yong Oh, Sun Jin Sym, Won Ki Kang and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02746796 (ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02746796 phase2 / phase3completednot on this map

ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer

TypeinterventionalSponsorOno Pharmaceutical Co., Ltd.Ran2016 to 2022Enrolled680ConditionsGastric CancerArmsONO-4538, Oxaliplatin, Tegafur- Gimeracil-Oteracil potassium, Capecitabine, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. ykkang@amc.seoul.kr.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Do-Youn OhDepartment of Oncology, Seoul National University Hospital, Seoul, Korea.
Sang Cheul OhDepartment of Hematology and Oncology, Korea University Guro Hospital, Seoul, Korea.
Sun Young RhaDepartment of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Ik Joo ChungDepartment of Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea.
Sung Yong OhDepartment of Oncology, Dong-A University College of Medicine, Busan, Korea.
Sun Jin SymDepartment of Oncology, Gachon University Gil Hospital, Incheon, Korea.
Won Ki KangDepartment of Hematology and Oncology, Samsung Medical Center, Seoul, Korea.
Jong Gwang KimDepartment of Oncology, Kyungpook National University Medical Center, Daegu, Korea.
Byoung Yong ShimDivision of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
In-Ho KimDivision of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Jin Young KimDepartment of Hematology and Oncology, Keimyung University Dongsan Medical Center, Daegu, Korea.
Eun-Kee SongDepartment of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Korea.
Hyo-Jin LeeDepartment of Oncology, Chungnam National University Hospital, Daejeon, Korea.
Seok Yun KangDepartment of Hematology-Oncology, Ajou University Hospital, Suwon, Korea.
Dong-Hoe KooDivision of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
So Yeon OhDepartment of Oncology, Pusan National University Yangsan Hospital, Yangsan, Korea.

Funding

BristolMyers Squibb K.KOno Pharmaceutical Co., Ltd
6 · The paper itself

Abstract

purposeWe report the safety and efficacy of nivolumab+chemotherapy for first-line treatment of advanced or recurrent gastric or gastroesophageal junction cancer in the Korean subpopulation of the ATTRACTION-4 clinical trial. MATERIALS AND

methodsATTRACTION-4 (NCT02746796) was a double-blind, randomized, placebo-controlled clinical trial of patients aged ≥ 20 years with histologically confirmed unresectable advanced or recurrent gastric or gastroesophageal junction cancer. Patients received nivolumab or placebo, both combined with physician-choice chemotherapy (oxaliplatin plus oral S-1 [tegafur-gimeracil-oteracil] [SOX] or oral capecitabine [CAPOX]).

resultsOverall, 464 patients were initially screened in Korea and 291 were randomized to nivolumab+chemotherapy (total/SOX/CAPOX: 148/66/82 patients) or placebo+chemotherapy (total/SOX/CAPOX: 143/61/82 patients). Centrally assessed progression-free survival (median, 14.75 vs. 8.34 months; hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.39 to 0.73; p < 0.001), overall survival (19.7 vs. 14.9 months; HR, 0.78; 95% CI, 0.60 to 1.02; p=0.065), overall response rate (54.7% vs. 47.6%), and duration of response (16.03 vs. 9.86 months) favored nivolumab+chemotherapy vs. placebo+chemotherapy. Grade ≥ 3 treatment-related adverse events (TRAEs) (56.1% vs. 44.1%), and any-grade endocrine (9.5% vs. 4.2%), hepatic (23.0% vs. 14.7%), hypersensitivity and infusion reactions (15.5% vs. 7.0%), renal (4.1% vs. 0.7%), and skin (44.6% vs. 23.1%) TRAEs tended to be more frequent in the nivolumab+chemotherapy group.

conclusionThese findings demonstrate the clinical benefit of nivolumab combined with chemotherapy (either SOX or CAPOX) for first-line treatment of gastric cancer/gastroesophageal junction cancer in Korean patients.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophagogastric JunctionNeoplasm Recurrence, LocalNivolumabStomach NeoplasmsAdultAgedDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleHumansMaleMiddle AgedRepublic of KoreaTegafurERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesNivolumabTegafurCapecitabineGastroesophageal junction cancerNivolumabOxaliplatin-based chemotherapyS-1Stomach neoplasms

Identifiers

PMID40610007
PMCPMC13382558

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.