A phase II study of S-1 plus resminostat for biliary tract cancer
- Conditions
- biliary tract cancer
- Registration Number
- JPRN-jRCT2080223827
- Lead Sponsor
- Yakult Honsha Co., Ltd.
- Brief Summary
Resminostat plus S-1 therapy improved neither PFS nor OS for patients with pre-treated BTCs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 101
1. Patients with unresectable/recurrent BTC (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or carcinoma of the ampulla of vater)
2. Patients who have received only one regimen systemic chemotherapy with platinum-gemcitabine for BTC
3. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
4. Patients who are able to ingest agents orally
1. Patients who have taken HDAC inhibitor
2. Pregnant women, lactating mothers or women of childbearing potential, or patients who are not using adequate contraception
3. Patients with brain metastases or suspected brain metastases based on the clinical symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method