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NCT05640791

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Status unknown Phase 2 Last updated 7 December 2022
What this trial tests

Phase 2 trial testing Cisplatin in Resectable Biliary Tract Cancer in 40 participants. Status unknown.

Timeline
1 December 2022
Primary endpoint
31 December 2023
31 December 2024

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment40
Start date1 December 2022
Primary completion31 December 2023
Estimated completion31 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 75, any sex, with Resectable Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Design of studies on neoadjuvant therapy for intrahepatic cholangiocarcinoma.
    Cheng Y, Li X. · · 2025 · cited 2× · PMID 39897772 · DOI 10.1016/j.heliyon.2024.e41356
  2. Immune-Checkpoint Inhibitors for Biliary Tract Cancer: Who Benefits and What Is Next?
    Ceniceros L, Torre M, Landa Magdalena A, Sangro P, et al · · 2025 · cited 1× · PMID 40940908 · DOI 10.3390/cancers17172811
  3. Macrophage-rich niches regulate T cell dynamics at the liver invasive margin during gallbladder cancer progression
    Li M, Liu Z, Shan S, Jia Z, et al ·

Verify or expand the search:

Other trials of Cisplatin

Trials testing the same drug.

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05640791.

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