NCT06037980

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. High risk for recurrence, for which patients will be eligible for study, is defined by the presence of at least one of the following risk features, as evaluated at baseline (pre-surgery): 1. For cholangiocarcinoma: * Suspected or definite locoregional lymph node involvement in the absence of jaundice (at least one of the following): * positive FNA cytology (obtained by EUS). * positive locoregional lymph nodes at PET-CT. * suspected positive locoregional lymph nodes at imaging (CT or MRI scan) according to local MTD discussion (eg. short axis \> 1.5 cm, contrast enhancement uptake, round shape, restriction at DWI). * Macrovascular invasion at preoperative CT scan. * Expected R1 resection due to proximity to major intrahepatic vascular and biliary structures. * For iCCA, presence of satellitosis or multifocal disease or radiological suspicion of tumoral diaphragmatic adhesion. * For iCCA, size of the liver lesion \>5 cm. * For eCCA, size of the primary lesion \> 3cm. * Ca19.9 \>100 U/mL. 2. For GBC: * Incidentally Detected Gallbladder Carcinoma (IGBC) After Simple Cholecystectomy with indication for radical second surgery (\>pT2) or newly diagnosed GBC.

Conditions

• Biliary Tract Cancer
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	◦ Gemcitabine 800 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles
DRUG	Nab paclitaxel	◦ Nab-paclitaxel 100 mg/mq, day 1 and 8 of 21-day cycles, for 3 cycles
DRUG	Cisplatin	◦ Cisplatin 25 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles
PROCEDURE	Curative Surgery	Curative surgery on primary tumor
DRUG	Capecitabine	1250 mg/m2 given orally twice daily on days 1 to 14 of a 3 weekly cycle for a total of 8 cycles

Timeline

• Start date: 2023-11-07
• Primary completion: 2028-12-01
• Completion: 2029-01-01
• First posted: 2023-09-14
• Last updated: 2025-02-17

Locations

19 sites across 1 country: Italy