Trial reportJapanese journal of clinical oncology2016
Randomized Phase III study of gemcitabine plus S-1 versus gemcitabine plus cisplatin in advanced biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1113, FUGA-BT).
Trial report in Japanese journal of clinical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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.
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.
Who cites it
25 citing papers in PubMed, 53 citations in OpenAlex.
- Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA).Journal of hepato-biliary-pancreatic sciences · 2023Trial
- Predictive factors of the treatment outcome in patients with advanced biliary tract cancer receiving gemcitabine plus cisplatin as first-line chemotherapy.Journal of gastroenterology · 2019Trial
- Predictive Value of Early Skin Rash in Cetuximab-Based Therapy of Advanced Biliary Tract Cancer.Pathology oncology research : POR · 2018Trial
- A Case of Unresectable Ampulla of Vater Carcinoma Successfully Treated with Conversion Surgery Following Sequential Systemic Chemotherapy Including Durvalumab.Surgical case reports · 2026Article
- Combined Chemotherapy-Immunotherapy for Advanced Biliary Tract Cancer (BTC): A Clinical, Genomic, and Biomarker Analysis.Journal of gastrointestinal cancer · 2025Article
- A case of successful conversion surgery for unresectable gallbladder cancer treated with durvalumab in combination with gemcitabine plus cisplatin.Clinical journal of gastroenterology · 2025Article
- Long-term survival after targeted therapy plus immunotherapy without chemotherapy in advanced gallbladder carcinoma: a case report and literature review.Frontiers in immunology · 2025Review
- Clinical utility of a comprehensive genomic profiling test for patient with advanced biliary tract cancer.International journal of clinical oncology · 2024Observational
- A case of rapidly progressing sarcomatous intrahepatic cholangiocarcinoma with suddenly appearing lymph node metastasis.Surgical case reports · 2024Article
- An age-group analysis on the efficacy of chemotherapy in older adult patients with metastatic biliary tract cancer: a Japanese cancer registry cohort study.BMC gastroenterology · 2023Article
- Advances in the systemic treatment of therapeutic approaches in biliary tract cancer.ESMO open · 2022Review
- Insights From the Analysis of Clinicopathological and Prognostic Factors in Patients With Gallbladder Cancer.Frontiers in oncology · 2022Article
- The efficacy and safety of apatinib treatment for patients with advanced or recurrent biliary tract cancer: a retrospective study.BMC cancer · 2021Observational
- Promising Molecular Targets for the Targeted Therapy of Biliary Tract Cancers: An Overview.OncoTargets and therapy · 2021Review
- Cholangiocarcinoma: State of the Art.Journal of gastrointestinal cancer · 2020Review
- Therapy of Primary Liver Cancer.Innovation (Cambridge (Mass.)) · 2020Review
- Integrative clinical and molecular analysis of advanced biliary tract cancers on immune checkpoint blockade reveals potential markers of response.Clinical and translational medicine · 2020Article
- A case of extrahepatic bile duct cancer with distant metastases showing pathological complete response to treatment combining gemcitabine and cisplatin.Clinical journal of gastroenterology · 2019Article
- Diagnostic-therapeutic management of bile duct cancer.World journal of clinical cases · 2019Review
- Radical resection of an initially unresectable intrahepatic cholangiocarcinoma after chemotherapy with using gemcitabine, cisplatin, and S-1: report of a case.Surgical case reports · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A Phase II selection design trial was conducted to identify the most promising regimen for comparison with standard therapy in chemo-naive patients with unresectable or recurrent biliary tract cancer (JCOG0805). Gemcitabine plus S-1 therapy showed better efficacy than S-1 monotherapy with acceptable safety in JCOG0805 study. Based on this result, a randomized Phase III trial was started in May 2013 to confirm the non-inferiority of gemcitabine plus S-1 therapy relative to gemcitabine plus cisplatin therapy, which is the current standard treatment for chemo-naive patients with unresectable or recurrent biliary tract cancer. A total of 350 patients will be accrued from 32 Japanese institutions within 4 years. The primary endpoint is overall survival, while the secondary endpoints are progression-free survival, adverse events, serious adverse events, clinically significant adverse events, response rate and %planned dose. This trial has been registered with the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm) and the registration number is UMIN000010667.
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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.