Evidence map›Paper›PMID 35900311›Full record

Trial reportJournal of hepato-biliary-pancreatic sciences2023

Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA).

Tatsuya Ioka, Masashi Kanai, Shogo Kobayashi, Daisuke Sakai, Hidetoshi Eguchi, Hideo Baba, Satoru Seo, Akinobu Taketomi, Tadatoshi Takayama, Hiroki Yamaue and 12 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hepato-biliary-pancreatic sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06903273 (Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Patients with Resectable High-risk Intrahepatic Cholangiocarcinoma), which is not on this map. Cited by 189 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
189citing papers in PubMed, 9 pooled it
41.8field-weighted citation impact, top 1% of its field
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.

NCT06903273 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Patients with Resectable High-risk Intrahepatic Cholangiocarcinoma

TypeinterventionalSponsorNational Cheng-Kung University HospitalRan2025 to 2029Enrolled35ConditionsCholangiocarcinoma, Biliary Tract Cancer (BTC)ArmsTislelizumab
3 · Its place in the literature

Who cites it

189 citing papers in PubMed, 9 syntheses or guidelines pooled it, 230 citations in OpenAlex.

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129 more citing papers are in PubMed but not listed here.

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

22 authors at 18 institutions in 1 country.

Tatsuya IokaDepartment of Oncology Center, Yamaguchi University Hospital, Yamaguchi, Japan.ORCID https://orcid.org/0000-0002-0197-1832
Masashi KanaiDepartment of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.
Shogo KobayashiDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University, Osaka, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.ORCID https://orcid.org/0000-0002-2318-1129
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.
Satoru SeoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID https://orcid.org/0000-0001-9539-8098
Akinobu TaketomiDepartment of Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.
Tadatoshi TakayamaDepartment of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Hiroki YamaueSecond Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.
Masahiro TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Sendai, Japan.
Masayuki ShoDepartment of Surgery, Nara Medical University, Nara, Japan.ORCID https://orcid.org/0000-0002-6208-7661
Keiko KameiDepartment of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
Jiro FujimotoDepartment of Gastroenterological Surgery, Hyogo College of Medicine, Hyogo, Japan.
Masanori ToyodaDepartment of Medical Oncology/Hematology, Kobe University Hospital and Graduate School of Medicine, Hyogo, Japan.
Junzo ShimizuDepartment of Surgery, Toyonaka Municipal Hospital, Osaka, Japan.
Takuma GotoDivision of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, Hokkaido, Japan.
Yoshitaro ShindoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.ORCID https://orcid.org/0000-0001-7419-5638
Kenichi YoshimuraMedical Center for Clinical and Translational Research, Hiroshima University Hospital, Hiroshima, Japan.
Etsuro HatanoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hiroaki NaganoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Kansai Hepatobiliary Oncology Group (KHBO)
Kyoto University · JPThe University of Osaka · JPYamaguchi University · JPAsahikawa Medical University · JPHiroshima University Hospital · JPHokkaido University · JPHyogo Medical University · JPJapan Society of Chemotherapy · JPKindai University · JPKobe University Hospital · JPKumamoto University · JPKyoto Medical Center · JPNara Medical University · JPNihon University · JPOsaka International Cancer Institute · JPTohoku University Hospital · JPToyonaka Municipal Hospital · JPWakayama Medical University · JP

Funding

Taiho Pharmaceutical
6 · The paper itself

Abstract

backgroundGemcitabine/cisplatin (GC) combination therapy has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). No randomized clinical trials have been able to demonstrate the survival benefit over GC during the past decade. In our previous phase II trial, adding S-1 to GC (GCS) showed promising efficacy and we aimed to determine whether GCS could improve overall survival compared with GC for patients with advanced BTC.

methodsWe performed a mulitcenter, randomized phase III trial across 39 centers. Enrolled patients were randomly allocated (1:1) to either the GCS or GC arm. The GCS regimen comprised gemcitabine (1000 mg/m

resultsBetween July 2014 and February 2016, 246 patients were enrolled. The median OS and 1-year OS rate were 13.5 months and 59.4% in the GCS arm and 12.6 months and 53.7% in the GC arm, respectively (hazard ratio [HR] 0.79, 90% confidence interval [CI]: 0.628-0.996; P = .046 [stratified log-rank test]). Median PFS was 7.4 months in the GCS arm and 5.5 months in the GC arm (HR 0.75, 95% CI: 0.577-0.970; P = .015). RR was 41.5% in the GCS arm and 15.0% in the GC arm. Grade 3 or worse AEs did not show significant differences between the two arms.

conclusionsGCS is the first regimen which demonstrated survival benefits as well as higher RR over GC in a randomized phase III trial and could be the new first-line standard chemotherapy for advanced BTC. To exploit the advantage of its high RR, GCS is now tested in the neoadjuvant setting in a randomized phase III trial for potentially resectable BTC.

Indexed as

Bile Duct NeoplasmsBiliary Tract NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineGemcitabineHumansTreatment OutcomeCisplatinDeoxycytidineGemcitabinebiliary tract cancercisplatingemcitabineS-1

Identifiers

PMID35900311
PMCPMC10086809
OpenAlexW4288425344

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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.