A Phase II/III Randomized Clinical Trial of 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: PURITY Study

NCT06037980 Phase 2/Phase 3 RECRUITING

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.

Details

Lead sponsor	Gruppo Oncologico del Nord-Ovest
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	300
Start date	2023-11-07
Completion	2029-01

Conditions

• Biliary Tract Cancer
• Cholangiocarcinoma

Interventions

• Gemcitabine
• Nab paclitaxel
• Cisplatin
• Curative Surgery
• Capecitabine

Primary outcomes

• 12-month progression-free survival (PFS) rate — 12 months
  the proportion of patients alive and free from progression/post-resection recurrence by 12-months timepoint from randomization (to be considered as primary endpoint in the phase II part of the study and as secondary endpoint in the phase III part of the study).
• median PFS — From date of randomization until the date of first documented progression (as assessed by radiological evaluation and clinical examination) or date of death from any cause, whichever came first, assessed up to 120 months
  i.e. the time from randomization to disease progression, post-resection recurrence or death from any cause (to be considered as secondary endpoint in the phase II part of the study and as primary endpoint in the phase III part of the study).

Countries

Italy