A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Sponsor
Yonsei University
Study ID
NCT07269158
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Cancer
  • Biliary Tract Neoplasms
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

"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.

Key Dates

Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy Maintenance
    Durvalumab or Pembrolizumab
  • Active Comparator: Immunotherapy Maintenance + Lenvatinib
    Durvalumab or Pembrolizumab + Levnatinib
  • Active Comparator: Immunotherapy Maintenance + Venadaparib
    Durvalumab or Pembrolizumab + Venadaparib
  • Active Comparator: Immunotherapy Maintenance + SCL-3010
    Durvalumab or Pembrolizumab + SCL-3010

Primary Outcome Measure

Phase Ib: Recommended Phase II Dose [ Time Frame: Up to 4 years ]

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