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  

Cholangiocarcinoma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cholangiocarcinoma
• Recurrence

• NCT number: NCT06037980
• Study type: Interventional
• Source: Gruppo Oncologico del Nord-Ovest
• Contact: Monica Niger, MD
• Phone: 02 2390 2919
• Email: monica.niger@istitutotumori.mi.it
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 7, 2023
• Completion date: January 2029