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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 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • Monica Niger, MD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  • Monica Niger, MD · 02 2390 2919

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06037980 on ClinicalTrials.gov