Evidence map›Paper›PMID 41243312›Full record

Trial reportJournal of hepato-biliary-pancreatic sciences2026

Neoadjuvant Chemotherapy With Gemcitabine/Cisplatin/S-1 for Resectable Biliary Tract Cancer With FDG-PET-Positive Lymph Node Metastasis (KHBO1201): A Multicenter Phase II Trial.

Satoshi Ogiso, Etsuro Hatano, Satoru Seo, Masashi Kanai, Shogo Kobayashi, Hiroshi Wada, Hidetoshi Eguchi, Tatsuya Higashi, Hiroaki Nagano, Tatsuya Ioka

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of hepato-biliary-pancreatic sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Satoshi OgisoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Etsuro HatanoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID https://orcid.org/0000-0003-3407-1918
Satoru SeoDepartment of Surgery, Kochi Medical School, Nankoku-City, Kochi, Japan.
Masashi KanaiDepartment of Clinical Oncology, Kyoto University Hospital, Kyoto, Japan.
Shogo KobayashiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.ORCID https://orcid.org/0000-0002-8828-1067
Hiroshi WadaDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.ORCID https://orcid.org/0000-0001-8862-7833
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.ORCID https://orcid.org/0000-0002-2318-1129
Tatsuya HigashiDepartment of Molecular Imaging and Theranostics, Institute for Quantum Medical Science, National Institutes for Quantum Science and Technology, Chiba, Japan.
Hiroaki NaganoDepartment of Gastroenterological, Breast and Endocrine Surgery, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan.ORCID https://orcid.org/0000-0002-7074-3315
Tatsuya IokaDepartment of Oncology Center, Yamaguchi University Hospital, Yamaguchi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of neoadjuvant gemcitabine, cisplatin, and S-1 (GCS) chemotherapy for resectable biliary tract cancer (BTC) and FDG-PET-positive lymph nodes in a multicenter phase II study (KHBO1201).

methodsPatients with resectable BTC (intrahepatic/extrahepatic bile duct, gallbladder, or ampullary cancers) and FDG-PET-positive lymph nodes received GCS chemotherapy: gemcitabine/cisplatin on Day 1 and oral S-1 for 7 days, repeated every 2 weeks for 3-6 cycles. Surgery was planned 4-8 weeks later if the tumor was deemed resectable. The primary endpoint was the curative resection rate. Secondary endpoints were the completion rate, radiological response, radiological/pathological complete response (CR) of FDG-PET-positive lymph nodes, and 1-year survival (UMIN000009831).

resultsTwenty-five patients were enrolled. Twenty-three (92%) completed GCS without treatment-related deaths; grade 3 biliary infection occurred in 8.0%. Curative resection was achieved in 60% with a morbidity rate of 40%. The radiological response rate was 13%, and the radiological and pathological CR rates of FDG-PET-positive lymph nodes were 24% and 28%, respectively. The 1-year survival rate was 75%.

conclusionsNeoadjuvant GCS chemotherapy is safe, feasible, and potentially effective for resectable BTC with FDG-PET-positive lymph nodes. A randomized phase III trial (JCOG1920) is underway to compare neoadjuvant GCS chemotherapy with upfront surgery (jRCTs031200388).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineAdultAgedCisplatinDrug CombinationsFemaleFluorodeoxyglucose F18GemcitabineHumansLymphatic MetastasisLymph NodesMaleMiddle AgedNeoadjuvant TherapyCisplatinDeoxycytidineDrug CombinationsFluorodeoxyglucose F18GemcitabineOxonic AcidRadiopharmaceuticalsS 1 (combination)Tegafurbiliary tract neoplasmschemotherapylymphatic metastasisneoadjuvant therapypositron‐emission tomography

Identifiers

PMID41243312
PMCPMC12924111

What OpenQuestion holds

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Registered trials

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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.