Trial reportInvestigational new drugs2012
Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine.
Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
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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
33 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Therapy for advanced cholangiocarcinoma: Current knowledge and future potential.Journal of cellular and molecular medicine · 2021Pooled it
- Trial
- 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
- A phase II FOLFOX-4 regimen as second-line treatment in advanced biliary tract cancer refractory to gemcitabine/cisplatin.Journal of chemotherapy (Florence, Italy) · 2014Trial
- A multicenter phase II study of S-1 for gemcitabine-refractory biliary tract cancer.Cancer chemotherapy and pharmacology · 2013Trial
- Pharmacokinetic evaluation of novel oral fluorouracil antitumor drug S-1 in Chinese cancer patients.Acta pharmacologica Sinica · 2013Trial
- Advancing systemic therapy for biliary tract cancer: current strategies and emerging paradigms.Frontiers in oncology · 2026Review
- Clinicomolecular Profile and Efficacy of Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Therapy forJCO precision oncology · 2025Article
- Nab-paclitaxel-based chemotherapy with or without anti-PD-(L)1 immunotherapy as a second-line treatment for advanced biliary tract cancer: a real-world retrospective study.Therapeutic advances in medical oncology · 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
- 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
- Liver Cancer Study Group of Japan Clinical Practice Guidelines for Intrahepatic Cholangiocarcinoma.Liver cancer · 2022Article
- 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
- A phase II study of S-1 and cisplatin with concurrent thoracic radiotherapy followed by durvalumab for unresectable, locally advanced non-small-cell lung cancer in Japan (SAMURAI study).Therapeutic advances in medical oncology · 2021Article
- Review
- 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
- Second-line chemotherapy in patients with advanced or recurrent biliary tract cancer: a single center, retrospective analysis of 294 cases.Investigational new drugs · 2018Article
- New Horizons for Precision Medicine in Biliary Tract Cancers.Cancer discovery · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Gemcitabine is widely used for the treatment of advanced biliary tract cancer (BTC) as first-line chemotherapy. However, there is no standard chemotherapy for patient with advanced BTC refractory to gemcitabine. We conducted a multicenter phase II study of S-1 monotherapy as second-line chemotherapy for patients with advanced BTC that were refractory to gemcitabine. S-1 was administered orally at a dose of 80 mg/m(2) for 28 days, followed by 14 days of rest. This regimen was repeated every 6 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty-two patients were enrolled between March 2007 and January 2010, with 14 patients (64%) representing cases of recurrence after surgery. The overall response rate was 22.7%, and the overall disease control rate was 50.0%. The median overall survival time was 13.5 months (95% CI, 7.1-23.1 months) and the median time-to-progression was 5.4 months (95% CI, 2.6-17.2 months). Grade 3/4 toxicities included neutropenia (5%) and anemia (5%). The most common non-hematological toxicities were nausea (27%), anorexia (55%), and pigmentation (32%). In conclusion, S-1 monotherapy is feasible and moderately efficacious second-line chemotherapy for advanced 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.