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Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

NCT05640791 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-12-07

No results posted yet for this study

Summary

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.

Conditions

  • Resectable Biliary Tract Cancer

Interventions

DRUG

Cisplatin

25mg/m2；d1, 8, 21 d cycle

DRUG

Gemcitabine

1000mg/m2；d1, 8, 21 d cycle

DRUG

Nab-paclitaxel

100mg/m2；d1, 8, 21 d cycle

DRUG

Durvalumab

1000mg；d1, 21 d cycle

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640791 on ClinicalTrials.gov