A Phase 2 interventional study of Gemcitabine, and S-1 in Biliary Tract Neoplasm, sponsored by Hallym University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-05-26.
Sponsored by Hallym University Medical Center · Phase 2, Interventional, and Treatment
This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in patient with advanced biliary tract cancer
Biliary-tract cancer (BTC) is invasive carcinoma that originates from the epithelial lining of the gallbladder and bile ducts. BTC include cholangiocarcinoma (intrahepatic, perihilar, and distal biliary-tree tumor) and carcinoma arising from the gallbladder.
Surgical resection of the primary tumor is potentially curative for BTC, but less than a quarter of patients are eligible for resection at presentation. Systemic chemotherapy is the principal treatment method for patients with unresectable or metastatic BTC.
Gemcitabine is a promising agent, which has shown efficacy in biliary tract cancer. As a single-agent therapy, gemcitabine shows response rates of 8-36% in BTC[4]. In phase II trials with patients in advanced BTC, gemcitabine in combination with capecitabine or platinum analogues produced objective response rates of 26-50%.
The ABC-02 study reported a significant survival advantage for gemcitabine and cisplatin over gemcitabine alone in patients with advanced BTC (median overall survival 11.7 vs. 8.1 months; P \< 0.001).
Oral anticancer drug S-1 consists of the 5-FU prodrug tegafur with two biochemical modulators, 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo). S-1 monotherapy is active against advanced BTC with objective response rates of 21-35%, and phase II trials of S-1 in combination with gemcitabine reported objective response rates of 20-36%. Differences between trials in the doses and administration schedules of gemcitabine and S-1 may be reflected in the ranges of efficacy, dose-intensity, and rates of toxicity observed.
Even though the efficacy of gemcitabine and S-1 combination is evident for patients with advanced BTC in previous phase II trials, there was no clinical study investigating the efficacy of gemcitabine and S-1 combination for patients with advanced BTC when this study was started. Therefore, we conducted a phase II study to evaluate gemcitabine and S-1 combination as first-line chemotherapy for patients with advanced BTC.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's enrollment of 38 is below the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.
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Drug: Gemcitabine, and S-1
Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m2 iv on day 1, 8 2. S-1 60 mg/day po on day 1-14
Also known as: Gemzar, TS-1
Objective reponse rate
Time frame: 1 year
Progression free survival, median overall survival, disease control rate, and over grade 3 hematologic toxicities (neutropenia, thrombocytopenia, and febrile neutropenia)
Time frame: 1 year
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Hallym University Medical Center