Clinical Trial

CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence

Study acronym: PURITY
Recruiting Phase 2/3
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Summary
PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-09-07; most recent amendment 2025-02-13.
Status change: Not Yet Recruiting → Recruiting 2023-11-13
Trial Details
NCT Number NCT06037980
Lead Sponsor Gruppo Oncologico del Nord-Ovest
Conditions Biliary Tract Cancer, Cholangiocarcinoma
Enrollment 300 participants
Start Date 2023-11-07
Primary Completion 2028-12 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-17