Durvalumab with Chemotherapy as First Line Treatment in Patients with Advanced Biliary Tract Cancers (aBTCs)
- Conditions
- Biliary Tract Cancer
- Registration Number
- JPRN-jRCT2061230037
- Lead Sponsor
- Sasaki Hidefumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Histologically confirmed, unresectable advanced or metastatic biliary tract carcinoma (BTC) including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma
- Participants with unresectable or metastatic BTC
-A World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0 to 2
-At least one lesion that qualifies as a Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) target lesion at baseline
- Adequate organ and bone marrow function
- Body weight of > 30 kg
- Negative pregnancy test (serum) for women of childbearing potential
- Female participants must be one year post-menopausal (amenorrhoeic for 12 months without an alternative medical cause)
- Male and female participants and their partners must be surgically sterile or on their chosen method of birth control as per the protocol.
-Any evidence of diseases such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations, history of uncontrolled or symptomatic cardiac disease, and history of allogenic organ transplant
-Active or prior documented autoimmune or inflammatory disorders
-History of another primary malignancy, except for malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study intervention
-History of leptomeningeal carcinomatosis
-History of active primary immunodeficiency
-Known to have tested positive for human immunodeficiency virus [HIV] (positive HIV 1/2 antibodies) or active tuberculosis infection
-Participants co-infected with Hepatitis B virus (HBV) and Hepatitis C virus (HCV) or co-infected with HBV and Hepatitis D virus (HDV)
-Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade > 2) caused by previous anticancer therapy
-History of, or current, brain metastases or spinal cord compression
-Known allergy or hypersensitivity to any of the study intervention or any of the study intervention excipients.
-Any concurrent chemotherapy, other than the one allowed in the study, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment
-Palliative radiotherapy with a limited field of radiation within 2 weeks of the first dose of study intervention, or radiotherapy with a wide field of radiation or radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
-Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
-Major surgical procedure within 28 days prior to the first dose of IMP
-Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
-Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants with Grade 3 or 4 possibly related adverse event (PRAE)
- Secondary Outcome Measures
Name Time Method - Overall Survival (OS)<br>- Objective Response Rate (ORR)<br>- Progression-Free Survival (PFS)<br>- Disease Control Rate (DCR)<br>- Duration of Response (DOR)<br>- Duration of Treatment (DOT)<br>- Number of participants with AEs, including PRAEs, adverse events of special interest (AESIs), immune-mediated adverse events (imAEs) and serious adverse events (SAEs)<br>- Number of participants with IRRs and hypersensitivity/anaphylactic reactions<br>- European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30)<br>- EORTC QLQ-BIL21 Score