Gastric Cancer最新文献

{"title":"Development of adenovirus-based oncolytic virus to induce EBV lytic reactivation.","authors":"Sun Hee Lee, Hyeji Byun, Donghyun Seo, Miyeon Cho, Ji-Hyeon Kim, Byung Woog Kang, Hyosun Cho, Hyojeung Kang","doi":"10.1007/s10120-025-01664-0","DOIUrl":"https://doi.org/10.1007/s10120-025-01664-0","url":null,"abstract":"<p><strong>Background: </strong>Oncolytic viruses (OVs) selectively replicate in and lyse tumor cells. Epstein-Barr virus-associated gastric carcinoma (EBVaGC), representing ~ 10% of gastric cancers globally, remains a therapeutic challenge. We developed Ad-TBZ, a novel oncolytic adenovirus engineered to selectively target EBVaGC by inducing EBV lytic reactivation.</p><p><strong>Methods: </strong>Ad-TBZ was constructed by inserting an hTERT promoter (hTERTp)-driven E1A/IRES-E1B cassette and a CMV promoter (CMVp)-driven BZLF1 gene into the adenoviral genome. We evaluated Ad-TBZ replication, cytotoxicity, and EBV lytic reactivation in EBVaGC cell lines (SNU719, NCC24, YCCEL1, AGS-EBV, MKN1-EBV), EBV-negative cells, and normal fibroblasts (CCD-986sk). In vivo efficacy was assessed using SNU719 and MKN1-EBV xenograft mouse models. Combination effects with platinum-based drugs and ganciclovir were also investigated.</p><p><strong>Results: </strong>Ad-TBZ selectively replicated in EBVaGC cells and demonstrated cell line-specific cytotoxic effects while sparing normal cells. It significantly upregulated EBV lytic genes (BRLF1, BMRF1, BGLF4, BXLF1, BALF4, BLLF1), increased viral genome copies, and induced cell line-specific late apoptosis. In vivo, Ad-TBZ effectively suppressed tumor growth in both xenograft models without systemic toxicity. Sequential treatment with oxaliplatin showed modest synergistic effects at specific concentrations in limited conditions, while most combination approaches showed no significant synergistic effects. These findings indicate Ad-TBZ functions optimally as a monotherapy.</p><p><strong>Conclusions: </strong>Ad-TBZ demonstrates potent and selective antitumor activity against EBVaGC through hTERTp-mediated selective replication and BZLF1-induced EBV lytic reactivation. These findings support Ad-TBZ as a promising novel monotherapeutic strategy for EBVaGC.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gallbladder edema as a clue to zolbetuximab-associated protein-losing enteropathy in gastric cancer: a case report.","authors":"Yoshihiko Kakiuchi, Shinji Kuroda, Shunya Hanzawa, Nobuhiko Kanaya, Hajime Kashima, Satoru Kikuchi, Kunitoshi Shigeyasu, Yoshiyasu Kono, Shunsuke Kagawa, Toshiyoshi Fujiwara","doi":"10.1007/s10120-025-01668-w","DOIUrl":"https://doi.org/10.1007/s10120-025-01668-w","url":null,"abstract":"<p><p>We report a rare case of protein-losing enteropathy (PLE) during zolbetuximab treatment in a 73-year-old woman with Stage IVB gastric cancer. After chemo-immunotherapy and curative surgery, 3rd-line treatment with capecitabine, oxaliplatin, and zolbetuximab was initiated due to recurrence. The patient developed persistent right upper abdominal pain; imaging revealed gallbladder wall edema, followed by mild gastric wall edema, despite unremarkable laboratory findings. Protein-losing scintigraphy demonstrated abnormal gastric protein leakage, leading to a diagnosis of PLE. While gastrointestinal toxicity is known with zolbetuximab, this is, to our knowledge, the first clinically diagnosed case of PLE in which gallbladder edema served as a diagnostic clue. As treatment strategies for advanced gastric cancer grow increasingly complex, achieving maximum therapeutic benefit requires not only optimal drug selection but also timely recognition and management of adverse events. With the broader use of zolbetuximab, clinicians should be mindful of this rare but potentially significant complication.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Classification based on tumor phenotypes enables the novel molecular characterization of esophagogastric junction cancer.","authors":"Kyota Takahashi, Keiichi Hatakeyama, Masanori Terashima, Takeshi Nagashima, Kenichi Urakami, Keiichi Ohshima, Atsushi Ochiai, Tadakazu Shimoda, Yusuke Koseki, Kenichiro Furukawa, Keiichi Fujiya, Yutaka Tanizawa, Yasuhiro Tsubosa, Etsuro Bando, Yae Kanai, Yasuto Akiyama, Ken Yamaguchi","doi":"10.1007/s10120-025-01665-z","DOIUrl":"https://doi.org/10.1007/s10120-025-01665-z","url":null,"abstract":"<p><strong>Background: </strong>The incidence of esophagogastric junction (EGJ) cancer is increasing worldwide. Siewert type II EGJ cancer encompasses intestinal and gastric phenotypes; however, the molecular profiles and clinicopathological features remain unclear.</p><p><strong>Methods: </strong>Overall, 922 patients who underwent surgical resection for EGJ or gastric cancer from 2014 to 2023 were analyzed. The tumors were classified into intestinal and gastric phenotypes using immunohistochemistry. Molecular profiling was conducted using whole-exome sequencing, and clinicopathological features, mutational patterns, immune responses, and survival outcomes were investigated.</p><p><strong>Results: </strong>The intestinal phenotype exhibited frequent TP53 mutations and high NOX1 expression. High NOX1 expression was correlated with increased CD4 + and CD20 + lymphocyte infiltration. The intestinal phenotype was associated with better relapse-free survival (RFS) than the gastric phenotype. Metastatic patterns varied, with peritoneal and lymph node metastases being more common in the gastric and intestinal phenotypes, respectively. High NOX1 expression was an independent prognostic factor for RFS.</p><p><strong>Conclusions: </strong>EGJ cancers with intestinal and gastric phenotypes demonstrate distinct molecular and immune profiles that influence prognosis. The intestinal phenotype, characterized by TP53 mutations, high NOX1 expression, increased immune cell infiltration, and better survival outcomes, may impact EGJ cancer prognosis and could guide future diagnostic and therapeutic approaches.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Textbook outcome in gastrectomy: useful metric or moving target? A scoping review.","authors":"Riadh Salem, Lorenzo Giorgi, Wing K Chou, Sheraz R Markar","doi":"10.1007/s10120-025-01659-x","DOIUrl":"https://doi.org/10.1007/s10120-025-01659-x","url":null,"abstract":"<p><strong>Background: </strong>Composite metrics including Textbook Outcome (TO) and Textbook Oncological Outcome (TOO) are increasingly utilised to assess quality in gastric cancer surgical research. However, inconsistent and variable reporting limits their clinical application.</p><p><strong>Objective: </strong>This scoping review aimed to catalogue definitions and criteria of TO and TOO in gastrectomy, report achievement rates and determinants, associations with survival outcomes, and identify methodological gaps.</p><p><strong>Methods: </strong>A search was conducted in MEDLINE, Embase, Web of Science, and Scopus from inception to April 2025. Eligible studies reported TO or TOO for adults undergoing curative-intent gastrectomy for cancer. Reviewers screened studies and extracted data on characteristics, definitions, achievement rates, and survival outcomes. Owing to heterogeneity, findings were summarised narratively.</p><p><strong>Results: </strong>Forty-five studies (published 2017-2025; n = 139,972 patients) were included. Definitions varied, with 26 unique components identified. Common components were adequate lymphadenectomy (≥ 15 nodes), absence of postoperative complications (Clavien-Dindo grade ≥ II), and no 30-day readmission. Median TO and TOO achievement rates were 58.6% (IQR: 37.6-75.8) and 30.3% (IQR: 23.6-40.2). The primary barriers were inadequate lymphadenectomy and CD ≥ II complications. Twelve studies reported a significant association between TO/TOO and improved overall and disease-free survival. Influencing factors included age, comorbidity, tumour characteristics, surgeon volume, and surgical approach. Limitations included non-standardised definitions, limited patient-reported outcomes, and a lack of prospective validation.</p><p><strong>Conclusion: </strong>TO and TOO are associated with improved survival in gastrectomy but are hampered by inconsistent definitions and limited prospective evidence. Standardisation, patient-reported outcomes, and prospective validation are needed to realise their potential as clinically useful quality metrics.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to comments on: intraoperative corticosteroid administration for resectable gastric cancer: a multicenter, randomized, open-label, phase II/III study.","authors":"Takaomi Hagi, Yukinori Kurokawa, Yuichiro Doki","doi":"10.1007/s10120-025-01667-x","DOIUrl":"https://doi.org/10.1007/s10120-025-01667-x","url":null,"abstract":"","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Minimally invasive versus open completion total gastrectomy for remnant gastric cancer: a nationwide propensity score-matched analysis.","authors":"Nobuhiro Nakazawa, Takashi Sakamoto, Hiroyuki Yamamoto, Akihiko Sano, Makoto Sakai, Shingo Kanaji, Hirotoshi Kikuchi, Hideki Ueno, Ken Shirabe, Hiroshi Saeki","doi":"10.1007/s10120-025-01663-1","DOIUrl":"https://doi.org/10.1007/s10120-025-01663-1","url":null,"abstract":"<p><strong>Background: </strong>Minimally invasive surgery (MIS) is increasingly used for gastric cancer; however, its application to remnant gastric cancer (RGC) remains technically challenging due to adhesions and altered anatomy. Large-scale comparative data on the safety and effectiveness of MIS versus open surgery for RGC are limited. This retrospective study aimed to evaluate the short-term outcomes of MIS versus open completion total gastrectomy for RGC.</p><p><strong>Methods: </strong>We retrospectively analyzed data from 3337 patients who underwent completion total gastrectomy for RGC between January 2018 and December 2022 using the National Clinical Database of Japan. After applying predefined inclusion criteria, we performed one-to-one propensity score matching to balance baseline characteristics between the MIS and open surgery groups and compared short-term surgical outcomes.</p><p><strong>Results: </strong>After matching, 540 patient pairs were included in the analysis. MIS was associated with a significantly longer operative time (median 344 vs. 248.5 min; P < 0.001) but reduced blood loss (median 70 vs. 290 mL; P < 0.001). The incidence of anastomotic leakage was higher in the MIS group (9.8% vs. 6.3%; P = 0.034). Postoperative hospital stay was numerically shorter in the MIS group (median 13 vs. 14 days; P = 0.065). Overall complication, reoperation, and mortality rates were comparable between groups.</p><p><strong>Conclusions: </strong>MIS for RGC showed comparable short-term outcomes to those of open surgery in a nationwide analysis, with advantages including reduced blood loss. However, the increased risk of anastomotic leakage highlights the need for careful patient selection and ongoing technical refinement.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical-radiomic prognostic model integrating staging before and after neoadjuvant chemotherapy in gastric cancer: a multicenter retrospective study.","authors":"Yizhou Wei, Siwei Pan, Yahan Tong, Guoliang Zheng, Mengxuan Cao, Yanqiang Zhang, Ruolan Zhang, Weiwei Zhu, Qing Yang, Ke Shen, Mengya Zhou, Ruixin Xu, Jintao He, Jiancheng Sun, Zhiyuan Xu, Xiangdong Cheng, Can Hu","doi":"10.1007/s10120-025-01661-3","DOIUrl":"https://doi.org/10.1007/s10120-025-01661-3","url":null,"abstract":"<p><strong>Background: </strong>Tumor regression grade (TRG) and ypTNM are primarily employed to evaluate the efficacy of Neoadjuvant chemotherapy (NAC) in gastric cancer (GC) patients, however, have limited prognostic value. In this study, we established a clinical-radiomic fusion model, without TRG information, for better prognosis assessment of patients following NAC.</p><p><strong>Methods: </strong>A retrospective multicenter study comprising 875 GC patients from three centers was conducted. Cox hazard regression model was used for variable screening and risk weight assignment. Lasso regression was applied for dimensionality reduction and screening of radiomic features. Models were constructed for better prognosis assessment, and were verified in external cohorts.</p><p><strong>Results: </strong>Survival analysis showed that dynamic T/N staging changes after NAC could effectively distinguish patients based on prognosis. Moreover, the Clinical SCORE model based on the dynamic T/N staging changes and other clinicopathological data had also been found in internal and external validations to be capable of effectively stratifying patients' risks. For CT images, the identified radiomics features were employed to establish the CT SCORE model, which was subsequently integrated with the Clinical SCORE model to construct the Final SCORE model for prognostic evaluation. In the training and validation cohorts, the prognostic discrimination performance of the Final SCORE model exceeded that of TRG and ypTNM. Furthermore, the final model might also be helpful for the screening of the population benefiting from postoperative adjuvant therapy.</p><p><strong>Conclusion: </strong>The developed clinical-radiomic Final SCORE model showed superior prognostic assessment performance than TRG and ypTNM for prognostic assessment of GC patients following NAC.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Angiotensin receptor blocker and angiotensin-converting enzyme inhibitor use and survival in gastric cancer patients: a Finnish nationwide cohort study.","authors":"Aliisa Auvinen, Panu Aaltonen, Harri Mustonen, Caj Haglund, Pauli Puolakkainen, Hanna Seppänen","doi":"10.1007/s10120-025-01662-2","DOIUrl":"https://doi.org/10.1007/s10120-025-01662-2","url":null,"abstract":"<p><strong>Background: </strong>The renin-angiotensin system (RAS) has been increasingly recognized to be associated with carcinogenesis and cancer progression. There is extensive preclinical evidence suggesting the benefits of RAS-inhibiting drugs, such as angiotensin receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs), in preventing the progression of gastric cancer (GC). However, clinical evidence supporting the positive effects of ARBs and ACEIs on GC prognosis is currently limited. The purpose of this study is to investigate their effects in a Finnish cohort.</p><p><strong>Methods: </strong>This is a retrospective national cohort study, where cancer patient registry data were linked to prescription purchase records for ARBs and ACEIs. The effect of ARB/ACEI in the post-diagnostic period on overall mortality was assessed using Cox regression analysis. Disease-specific mortality associations were evaluated with the Fine and Gray model.</p><p><strong>Results: </strong>We included 2246 histologically confirmed GC patients diagnosed between 2011 and 2016. Follow-up continued until the end of 2023. In the main analysis, a protective effect of ARB use was associated with a significant reduction in overall mortality (adjusted hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.69-0.94, p = 0.007). Furthermore, the effect was greater for those with higher ARB dosage. A similar finding was not observed with ACEI use. For disease-specific survival, both ARB and ACEI use had a significant protective effect (adjusted HR 0.75, 95% CI 0.62-0.90 p = 0.002 and adjusted HR 0.76, 95% CI 0.63-0.93, P = 0.007, respectively).</p><p><strong>Conclusions: </strong>Our study adds to the evidence that ARB use might have a beneficial impact on survival among GC patients.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a prognostic model incorporating patient reported outcomes for advanced gastric and esophageal carcinoma (AGOC) using individual patient data from two AGITG randomized clinical trials.","authors":"Sayeda Kamrun Naher, David Espinoza, Peter Grimison, Kohei Shitara, Nick Pavlakis, David Goldstein, Martin R Stockler, Rebecca Mercieca-Bebber, Katrin Marie Sjoquist","doi":"10.1007/s10120-025-01654-2","DOIUrl":"https://doi.org/10.1007/s10120-025-01654-2","url":null,"abstract":"<p><strong>Background: </strong>We developed and validated a prognostic model incorporating readily accessible clinicopathological data and specific patient-reported outcomes (PROs).</p><p><strong>Methods: </strong>We used data from two randomized trials comparing regorafenib to placebo: AGITG INTEGRATE IIa (n = 251) for model development and AGITG INTEGRATE (n = 152) for validation. Candidate variables were chosen from a systematic literature review and expert consultation. Significant prognostic factors in the multivariable model were identified using univariable Cox proportional hazards models with a p-value of < 0.1. Multivariable Cox proportional hazards models were developed using clinicopathological and PRO variables, with model selection refined using least absolute shrinkage and selection operator (LASSO). The model's discrimination and calibration were assessed using concordance indices (C-statistics) and calibration plots.</p><p><strong>Results: </strong>Univariable analysis identified 9 clinicopathological variables and 4 PRO domains that were prognostic for overall survival: body mass index (BMI), ECOG performance status, number of metastatic sites, liver involvement, treatment with regorafenib, neutrophil-lymphocyte ratio (NLR), LDH, albumin, CA 19-9, appetite loss, constipation, fatigue, and pain. The initial multivariable model (M1) incorporated geographic region (Asia vs non-Asia), performance status, number of metastatic sites, treatment with regorafenib, NLR, BMI, LDH, CA 19-9, and albumin. The preferred multivariable model (M2), including the abovementioned variables plus the 4 PROs, demonstrated superior discriminative ability with higher C-statistic values than models without PROs. Plots supported the model's calibration.</p><p><strong>Conclusions: </strong>Incorporating PROs into prognostic models for AGOC improved the accuracy of survival predictions. Further research is needed to validate its use in routine clinical practice.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Eligibility criteria in phase 3 randomized controlled trials in gastric cancer.","authors":"Katarzyna Marcisz-Grzanka, Danuta Kłosowska, Marek Harhala, Jan Borysowski","doi":"10.1007/s10120-025-01653-3","DOIUrl":"https://doi.org/10.1007/s10120-025-01653-3","url":null,"abstract":"<p><strong>Background: </strong>The purpose of this study was to examine the eligibility criteria in phase 3 randomized controlled trials (RCTs) in gastric cancer.</p><p><strong>Methods: </strong>The analysis included 207 RCTs of systemic treatments, started between 2009 and 2024, and registered at the WHO International Clinical Trials Registry Platform (ICTRP).</p><p><strong>Results: </strong>93 (44.9%) trials had an upper age limit of 85 years of age or lower (coprimary outcome). In multivariable analysis, these limits were less likely in RCTs with the sites located in North America (adjusted odds ratio [aOR], 0.06; 95% confidence interval [CI] 0.01-0.26; p < 0.001). Only 3 (1.4%) trials were specifically dedicated to older patients. 138 (66.7%) trials excluded patients with Eastern Cooperative Oncology Group (ECOG) score > 1 (coprimary outcome); these criteria were more likely in more recent trials (aOR, 4.49; 95% CI 2.11-9.94; p < 0.001). However, the odds of excluding individuals with ECOG score > 1 were not significantly associated with any type of the investigational treatment including chemotherapy (p > 0.05). Moreover, many trials excluded patients with brain metastases (n = 91; 44%) and those with comorbidities, most frequently liver disorders (n = 170; 82.1%). None of the RCTs excluded patients based on frailty.</p><p><strong>Conclusions: </strong>The eligibility criteria in phase 3 RCTs in gastric cancer are fairly strict. Recommendations presented in this article will allow the investigators to improve the enrollment of some clinically relevant populations of patients, especially older persons, individuals with inadequate performance status, and those with comorbidities, without substantially compromising the safety of trials participants.</p>","PeriodicalId":12684,"journal":{"name":"Gastric Cancer","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145033183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}