Trial reportCancer chemotherapy and pharmacology2013
A multicenter phase II study of S-1 for gemcitabine-refractory biliary tract cancer.
Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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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
23 citing papers in PubMed.
- Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- A pilot study of Pan-FGFR inhibitor ponatinib in patients with FGFR-altered advanced cholangiocarcinoma.Investigational new drugs · 2022Trial
- Trial
- Multicenter Phase II Trial of Axitinib Monotherapy for Gemcitabine-Based Chemotherapy Refractory Advanced Biliary Tract Cancer (AX-BC Study).The oncologist · 2021Trial
- Efficacy and safety of trametinib in Japanese patients with advanced biliary tract cancers refractory to gemcitabine.Cancer science · 2018Trial
- Phase 2 study of combination SPI-1620 with docetaxel as second-line advanced biliary tract cancer treatment.British journal of cancer · 2017Trial
- Concurrent radiotherapy with S-1 plus cisplatin versus concurrent radiotherapy with cisplatin alone for the treatment of locally advanced cervical carcinoma: a pilot randomised controlled trial.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016Trial
- Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine.Investigational new drugs · 2012Trial
- Advancing systemic therapy for biliary tract cancer: current strategies and emerging paradigms.Frontiers in oncology · 2026Review
- Clinical potential of antibody-drug conjugates in early-phase clinical trials for late-line treatment of advanced solid tumors.Investigational new drugs · 2025Article
- Initial adjustments in the dosage and rest period of gemcitabine plus cisplatin therapy for patients with incurable biliary tract cancer based on baseline estimated glomerular filtration rate (eGFR) values may be crucial for treatment outcomes and the preservation of renal function.Journal of gastrointestinal oncology · 2024Article
- Pemigatinib treatment for intrahepatic cholangiocarcinoma with FGFR2 fusion detected by a liquid comprehensive genomic profiling test.Clinical case reports · 2023Article
- Favorable Management of Repeated Serous Retinal Detachment with Continued Tumor Response in a Patient with Intrahepatic Cholangiocarcinoma during Treatment with Pemigatinib.Internal medicine (Tokyo, Japan) · 2023Article
- Clinical outcomes of second‑line chemotherapy after gemcitabine and cisplatin plus S‑1 treatment for patients with advanced biliary tract cancer in the KHBO1401‑3A study.Oncology reports · 2023Article
- Efficacy and safety of S-1 following gemcitabine with cisplatin for advanced biliary tract cancer.Investigational new drugs · 2021Article
- Chemotherapy for Biliary Tract Cancer in 2021.Journal of clinical medicine · 2021Review
- Development of Possible Next Line of Systemic Therapies for Gemcitabine-Resistant Biliary Tract Cancers: A Perspective from Clinical Trials.Biomolecules · 2021Review
- Phase I study of resminostat, an HDAC inhibitor, combined with S-1 in patients with pre-treated biliary tract or pancreatic cancer.Investigational new drugs · 2019Article
- Apatinib for treating advanced intrahepatic cholangiocarcinoma after failed chemotherapy: A case report and literature review.Medicine · 2018Review
- Biliary cancer: intrahepatic cholangiocarcinomaJournal of gastrointestinal oncology · 2017Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeGemcitabine (GEM)-based chemotherapy has been used worldwide as the first-line treatment for advanced biliary tract cancer (BTC). However, no standard regimens have been established yet for patients with GEM-refractory BTC. A previous phase II trial of S-1 as a first-line treatment in patients with advanced BTC revealed promising activity of this drug. The present study was conducted to evaluate the efficacy and safety of S-1 in patients with GEM-refractory BTC.
methodsThe subjects were patients with pathologically proven BTC who had shown disease progression while receiving GEM-based chemotherapy. Each treatment cycle consisted of administration of S-1 orally at the dose of 40 mg/m(2) twice daily for 28 days, followed by a rest period of 14 days. The primary endpoint of this study was objective response, and the secondary endpoints were the toxicity, progression-free survival (PFS), and overall survival (OS).
resultsForty patients were assessed for efficacy and safety from 8 hospitals in Japan between June 2007 and September 2008. There were 3 cases of confirmed partial response (7.5 %) and 22 patients (55 %) of stable disease. The median PFS and OS were 2.5 and 6.8 months, respectively. Toxicity was generally mild, and the most common grade 3 or 4 toxicities were anorexia (10.0 %), anemia (7.5 %), mucositis (7.5 %), hypoalbuminemia (5.0 %), and pneumonia (5.0 %). There were no treatment-related deaths.
conclusionsMonotherapy with S-1 was well tolerated, but showed modest efficacy in patients with GEM-refractory BTC.
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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.