Durvalumab with Chemotherapy as First Line Treatment in Patients with Advanced Biliary Tract Cancers (aBTCs)

JRCT ID: jRCT2061230037

Registered date:14/07/2023

Basic Information

• Recruitment status: Recruiting
• 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)

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
• 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
• Secondary ID(s): NCT05771480,2022-502043-35-00