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

JRCT ID: jRCTs031230380

Registered date:06/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary tract neoplasms
• Date of first enrollment: 28/11/2023
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Concurrent radiation and gemcitabine plus cisplatin with durvalumab

Outcome(s)

• Primary Outcome: Severe treatment-related adverse events, objective response rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ueno Makoto
• Secondary Sponsor: Furuse Junji
• Source(s) of Monetary Support: Japan Oncology Network in Hepatobiliary and Pancreas