Biliary Tract Neoplasm Clinical Trial
Official title:
Phase II Trial of Gemcitabine and S-1 for Patients With Advanced Biliary Tract Cancer
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02527824 -
Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer
|
Phase 2 | |
| Completed |
NCT01595217 -
MRCP Diagnoses EHCC Better When Combined DWI
|
N/A | |
| Recruiting |
NCT01542281 -
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer
|
N/A |