Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT05640791
Phase
PHASE2
Status
Unknown

Conditions

  • Resectable Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    25mg/m2；d1, 8, 21 d cycle
  • Gemcitabine — DRUG
    1000mg/m2；d1, 8, 21 d cycle
  • Nab-paclitaxel — DRUG
    100mg/m2；d1, 8, 21 d cycle
  • Durvalumab — DRUG
    1000mg；d1, 21 d cycle

Study Details

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.

Key Dates

Start date
Dec 1, 2022
Status verified
Nov 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine, cisplatin, nab-paclitaxel, durvalumab
    Participants receive nab-paclitaxel over 30 minutes, cisplatin over 60 minutes, and gemcitabine over 30 minutes on days 1 and 8; durvalumab over 60 minutes on days 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.

Primary Outcome Measure

Rate of completion of all preoperative and operative therapy [ Time Frame: Up to 9 weeks after study start ]

Central Contacts