A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in… (NCT07269158) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer
South Korea160 participantsStarted 2025-12
Plain-language summary
"Biliary tract cancer (BTC) is a rare malignancy with a poor prognosis. Most patients present with unresectable disease, and even after curative-intent resection, recurrence is common. Since the ABC-02 trial, gemcitabine plus cisplatin (Gem/Cis) has been established as the standard first-line regimen, but the median overall survival (OS) remains approximately 11.7 months. Recent studies combining immune checkpoint inhibitors (ICIs) such as durvalumab or pembrolizumab with Gem/Cis have improved OS to 12.7-12.9 months, establishing ICI-based combination therapy as the new standard. However, the optimal maintenance therapy following initial chemoimmunotherapy remains undefined.
This phase IIb study enrolls patients with advanced BTC who achieved disease control after at least eight cycles of Gem/Cis plus ICI. The trial compares the efficacy and safety of ICI monotherapy maintenance versus ICI in combination with lenvatinib, venadaparib, or interleukin-2 (IL-2, SLC-3010).
Lenvatinib, through inhibition of FGFR2 and modulation of the tumor immune microenvironment, is expected to enhance ICI efficacy. PARP inhibitors may be beneficial in patients with homologous recombination deficiency (HRD) or platinum-sensitive disease. Additionally, IL-2 can activate tumor-infiltrating lymphocytes and alleviate the immunosuppressive microenvironment, potentially augmenting ICI responsiveness.
This study aims to explore a novel maintenance strategy integrating molecular targeted therapy, DNA damage repair modulation, and cytokine-based immunotherapy to overcome the limitations of current ICI monotherapy in BTC. The combination approach is expected to improve disease control and survival outcomes in patients with advanced BTC.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓Patients with advanced biliary tract cancer who have completed at least 8 cycles of Durvalumab plus Gemcitabine and Cisplatin treatment without radiologic evidence of disease progression, and are planned to receive Durvalumab maintenance therapy.
Exclusion criteria
✕. Patients who have received more than 10 cycles of immune checkpoint inhibitor (ICI) plus Gemcitabine and Cisplatin combination therapy for advanced biliary tract cancer.
✕. Patients who have been treated for, or have evidence of recurrence or progression of, any malignancy other than biliary tract cancer within the past 3 years.
✕. Patients with residual adverse events from prior therapy or surgery that may interfere with the safety evaluation of the investigational product.
✕. Patients with a history of hypersensitivity to any component of monoclonal antibody products.
✕. Patients with a history or evidence of active, non-infectious interstitial lung disease (pneumonitis).
✕. Patients with symptomatic or clinically active brain or leptomeningeal metastases requiring treatment.
. Patients who are immunodeficient or are receiving systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first dose of the investigational product.
✕. Patients with uncontrolled or significant cardiovascular disease, defined as any of the following: