NIPH Clinical Trials Search

JRCT ID: jRCTs031230380

Registered date:06/10/2023

A multicenter single arm phase I study of concurrent radiation and gemcitabine plus cisplatin with durvalumab(MEDI4736) for advanced biliary tract cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBiliary tract neoplasms
Date of first enrollment28/11/2023
Target sample size36
Countries of recruitment
Study typeInterventional
Intervention(s)Concurrent radiation and gemcitabine plus cisplatin with durvalumab


Primary OutcomeSevere treatment-related adverse events, objective response rate
Secondary OutcomeAdverse events, treatment-related adverse events that have led to treatment discontinuation, disease control rate, time to response, duration of response, response of nonirradiated target lesions, progression-free survival, overall survival

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 79age old
Include criteria1) Histologically or cytologically proven adenocarcinoma 2) Unresectable or recurrent biliary tract cancer 3) No previous chemotherapy or radiotherapy for biliary tract cancer 4) Aged 20 to 79 years old 5) Body weight > 30 kg 6) ECOG performance status of 0 or 1 7) Presence of lesions with multiple sites 8) Presence of nonirradiated target lesions. 9) Presence of metastatic lesions amenable to radiotherapy 10) Oral intake is possible 11) Grade1or less of peripheral sensory neuropathy, peripheral motor neuropathy, and tinnitus 12) Preserved major organ function 13) Written informed consent
Exclude criteria1) Active double cancer 2) Receiving any combination of chemotherapy, investigational drugs, and biologic or hormonal therapy for the treatment of cancer 3) With previous radiotherapy 4) Active infection 5) Fever of 38 degrees Celsius or higher 6) Active autoimmune or inflammatory disease or a confirmed history of such disease 7) Taking antiplatelet or anticoagulant medication 8) Complicated by one or more of interstitial pneumonia, pulmonary fibrosis, or severe emphysema 9) Unhealed fistulas, ulcerative lesions, and active bleeding 10) Metastases to central nervous system 11) Moderate or severe ascites and/or pleural effusion 12) Severe complication 13) Poorly controlled diabetes 14) Pregnant or lactating women 15) Mental disorder 16) Patients who investigator regards as inappropriate for candidate

Related Information


Public contact
Name Naohiro Okano
Address 6-20-2 Shinkawa, Mitaka-shi, Tokyo Tokyo Japan 181-8611
Telephone +81-422-47-5511
Scientific contact
Name Makoto Ueno
Address 2-3-2 Nakao, Asahi, Yokohama, Kanagawa Kanagawa Japan 241-8515
Telephone +81-45-520-2222
Affiliation Kanagawa Cancer Center