Biliary tract neoplasms Chemoradiotherapy
Conditions
Interventions
Concurrent radiation and gemcitabine plus cisplatin with durvalumab
Sponsors
Ueno Makoto
Furuse Junji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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
Exclusion criteria
Exclusion criteria: 1) Active multiple primary neoplasms 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe treatment-related adverse events, objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse 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 | — |
Contacts
Public ContactNaohiro Okano
KYORIN UNIVERSITY HOSPITAL
Outcome results
None listed