Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborator: Jeil Pharmaceutical Co., Ltd.
• Treatments: Camptothecin; Irinotecan; Oxaliplatin; Tegafur

Criteria

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.