Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Cholangiocarcinoma

Biliary Tract Neoplasms

Disease Attributes

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment followed by surgery and adjuvant chemotherapy

Standard upfront surgery and adjuvant chemotherapy

◦ Gemcitabine 800 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

◦ Nab-paclitaxel 100 mg/mq, day 1 and 8 of 21-day cycles, for 3 cycles

Nab paclitaxel

◦ Cisplatin 25 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

Curative Surgery

1250 mg/m2 given orally twice daily on days 1 to 14 of a 3 weekly cycle for a total of 8 cycles

Monica Niger, MD

Federico Nichetti, MD

Rossana Berardi

Stefania Mosconi

Giovanni Brandi

Giuseppina Arcangeli

Elena Fea

Ilario Giovanni Rapposelli

Andrea Casadei Gardini

Federico Nichetti

Federica Palermo

Lorenza Rimassa

Salvatore Siena

Massimilano Salati

Raffaella Longarini

Francesca Bergamo

Salvatore Corallo

Lorenzo Fornaro

Stefano Tamberi

Lisa Salvatore

Massimo Di Maio

Davide Melisi

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.

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.

Prospective, open-label, multicenter, randomized phase II-III study

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

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).

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).

i.e. the time from randomization to disease progression that precludes definitive surgery, treatment discontinuation for any reason, post-resection recurrence, a second primary cancer, or death from any cause.

i.e. the time from surgery to disease recurrence or death in patients who undergo to surgery with curative intent.

i.e. the time from randomization to death or last follow-up for alive patients.

i.e. the percentage of patients, relative to the total of randomized patients, for whom a R0 resection is achieved.

i.e. the percentage of patients, relative to the total of randomized patients, for whom the tumor was macroscopically removed and the intent of surgery is considered curative.

QoL will be estimated with EORTC QLQ-C30; mean score changes from baseline, proportion of patients with improved, stable, or deteriorated scores from baseline and time to deterioration in the EORTC QLQ-C30 scores will be compared between the two arms. Time to deterioration will be defined as the time from baseline to the first onset of a 10-point or greater decrease (for functional scales)/increase (for symptoms scale) from baseline, with confirmation under the right-censoring rule. All available observations will be used to calculate time to deterioration.

QoL will be estimated with the module BIL21; mean score changes from baseline, proportion of patients with improved, stable, or deteriorated scores from baseline and time to deterioration in the BIL21 physical functioning, social functioning, and fatigue scores will be compared between the two arms. Time to deterioration was defined as the time from baseline to the first onset of a 10-point or greater decrease from baseline for functional scales or a 10-point or greater increase for symptom scales, with confirmation under the right-censoring rule. All available observations will be used to calculate time to deterioration.

of neoadjuvant therapy as per investigator assessment and central review, i.e. the percentage of patients, relative to the total of enrolled subjects receiving neoadjuvant treatment, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria.

i.e. the retrospective evaluation of patients with unresectable disease, as assessed by the central review committee, in the two arms, and of the rate of conversion to resectability in the neoadjuvant arm.

.e. the percentage of patients, relative to the total of subjects randomized to neoadjuvant treatment, experiencing a specific adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0).

i.e. the percentage of patients, relative to the total of enrolled subjects undergoing surgery, with any serious perioperative morbidity or mortality according to Clavien-Dindo classification.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT06037980	Biliary Tract C... Cholangiocarcin...	Gemcitabine Nab paclitaxel Cisplatin Curative Surger... Capecitabine	18 Years - 75 Years	Gruppo Oncologico del Nord-Ovest
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	NCT06037980	Biliary Tract C... Cholangiocarcin...	Gemcitabine Nab paclitaxel Cisplatin Curative Surger... Capecitabine	18 Years - 75 Years	Gruppo Oncologico del Nord-Ovest

Spots Global Cancer Trial Database for cisplatin gemcitabine nabpaclitaxel