JRCT ID: jRCT2061230037
Registered date:14/07/2023
Durvalumab with Chemotherapy as First Line Treatment in Patients with Advanced Biliary Tract Cancers (aBTCs)
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Biliary Tract Cancer |
Date of first enrollment | 15/09/2023 |
Target sample size | 35 |
Countries of recruitment | France,Japan,Germany,Japan,Italy,Japan,Korea, Republic of,Japan,Singapore,Japan,Spain,Japan,United States,Japan |
Study type | Interventional |
Intervention(s) | Durvalumab + Gemcitabine based chemotherapy - Durvalumab: Participants will receive 1500 mg every 3 weeks, or every 4 weeks (in combination with chemotherapy every 3 weeks, or every 2 weeks, respectively) from cycle 1 to cycle 8 of chemotherapy. Upon completion, participants will receive 1500 mg every 4 weeks (as monotherapy) - Gemcitabine monotherapy: Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) - Gemcitabine + cisplatin: Gemcitabine plus cisplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) for WHO/ECOG PS 2 participants only - Gemcitabine + oxaliplatin: Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) - Gemcitabine + carboplatin: Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) - Gemcitabine + cisplatin + S-1: Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks (i.e, 4 cycles of durvalumab) - Gemcitabine + S-1: Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) - Gemcitabine + cisplatin + albumin-bound paclitaxel: Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) |
Outcome(s)
Primary Outcome | Number of participants with Grade 3 or 4 possibly related adverse event (PRAE) |
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Secondary Outcome | - Overall Survival (OS) - Objective Response Rate (ORR) - Progression-Free Survival (PFS) - Disease Control Rate (DCR) - Duration of Response (DOR) - Duration of Treatment (DOT) - Number of participants with AEs, including PRAEs, adverse events of special interest (AESIs), immune-mediated adverse events (imAEs) and serious adverse events (SAEs) - Number of participants with IRRs and hypersensitivity/anaphylactic reactions - European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30) - EORTC QLQ-BIL21 Score |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 130age old |
Gender | Both |
Include criteria | - 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. |
Exclude criteria | -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 |
Related Information
Primary Sponsor | Sasaki Hidefumi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05771480,2022-502043-35-00 |
Contact
Public contact | |
Name | Chikako Rosario |
Address | Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo Tokyo Japan 104-0033 |
Telephone | +81-80-8929-3137 |
Clinicaltrial-registration@parexel.com | |
Affiliation | Parexel International Inc. |
Scientific contact | |
Name | Hidefumi Sasaki |
Address | Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo Tokyo Japan 104-0033 |
Telephone | +81-80-8937-1839 |
Hidefumi.Sasaki@parexel.com | |
Affiliation | Parexel International Inc. |