This trial is active, not recruiting.

Condition biliary tract neoplasm
Treatment oxaliplatin, irinotecan, s-1
Phase phase 2
Sponsor Hallym University Medical Center
Collaborator Jeil Pharmaceutical Co., Ltd.
Start date March 2015
End date August 2016
Trial size 31 participants
Trial identifier NCT02527824, HMC-HO-GI-1501


This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle. Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day 1-7
oxaliplatin, irinotecan, s-1 Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)
Treatment will be delivered every 2 weeks Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day1-7

Primary Outcomes

overall response rate
time frame: 1.5 year

Secondary Outcomes

progression free survival
time frame: 1.5 year
overall survival
time frame: 1.5 year
toxicity profiles - the number of participants and grade of intensity of treatment related adverse events
time frame: 1.5 year

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: - Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - More than 3 months expected life span - Measurable lesion by RECIST criteria version 1.1 - Palliative chemotherapy naive - Adequate organ functions - Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: - Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer. - Participants who had received radiation therapy for target lesions 4 weeks before study enrollment - Participants who had received major surgery 4 weeks before study enrollment - Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding - Participants with central nervous system(CNS) metastases - Participants with peripheral sensory neuropathies with impaired functional activities - Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.

Additional Information

Official title Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
Principal investigator Dae Young Zang, MD, PhD
Description It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy. S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hallym University Medical Center.