Actively Recruiting
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
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2025-02-17
300
Participants Needed
19
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient able and willing to provide written informed consent and comply with study protocol and planned surgery
- Male or female aged 18 to under 75 years
- Histologically or cytologically confirmed non-metastatic resectable biliary tract cancer, including gallbladder carcinoma and intrahepatic, perihilar or distal cholangiocarcinoma
- Availability of a tumor sample
- ECOG performance status of 0 or 1
- No prior tumor resection for biliary tract cancer
- No distant metastases confirmed by CT, MRI, and PET scans
- Technically resectable tumor as assessed by local multidisciplinary team with relevant expertise
- High risk for recurrence defined by specific clinical features such as lymph node involvement, tumor size, macrovascular invasion, or elevated Ca19.9
- Estimated life expectancy greater than 3 months
- Adequate blood cell counts: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL
- Adequate liver function: serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, AST and/or ALT < 3 x ULN
- Adequate kidney function with serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Adequate coagulation function (INR ≤ 1.5, PTT ≤ 5 seconds above ULN unless on anticoagulants)
- No complete deficiency of dihydropyrimidine dehydrogenase enzyme (DPD) confirmed by gene testing
- Females of childbearing potential agree to abstain or use effective contraception during treatment and 7 months after last dose
- Males agree to abstain or use effective contraception during treatment and 7 months after last dose
- Negative pregnancy test within 7 days before treatment for premenopausal women
- Agreement not to donate eggs or sperm during study and 7 months after last treatment
You will not qualify if you...
- Known allergy or hypersensitivity to study drugs
- Active or progressing additional malignancy or history of other malignancy within 2 years (except certain skin, cervical, or prostate cancers)
- Locally unresectable tumor as assessed by multidisciplinary team
- Evidence of distant metastases
- Tumor requiring complex multi-step surgery due to inadequate future liver remnant
- Cirrhosis at Child-Pugh B level or worse or recent hepatic decompensation
- Active uncontrolled hepatitis B or C infections
- Recent systemic antibiotic or antifungal treatment for active infection
- Uncontrolled HIV infection or low CD4 count
- Pregnant, breastfeeding, or planning pregnancy during study and 7 months after
- Concurrent antineoplastic treatments including radiotherapy
- Prior systemic therapy for biliary tract cancer
- Prior surgery or local therapy for biliary tract cancer
- Severe or uncontrolled cardiovascular disease
- Psychiatric disorder preventing informed consent
- Serious underlying medical conditions impairing participation
- Complete dihydropyrimidine dehydrogenase enzyme deficiency
- Inability to take oral medication or malabsorption syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Ospedali Riuniti di Ancona
Ancona, Italy
Not Yet Recruiting
2
ASST Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
3
Oncologia Medica Policlinico Sant'Orsola - Malpighi
Bologna, Italy
Not Yet Recruiting
4
ASST Spedali Civili
Brescia, Italy
Not Yet Recruiting
5
Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Not Yet Recruiting
6
IRST Dino Amadori
Meldola, Italy
Not Yet Recruiting
7
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
8
Humanitas Cancer Center
Milan, Italy
Not Yet Recruiting
9
Ospedale Niguarda Cancer Center
Milan, Italy
Not Yet Recruiting
10
Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
11
Università di Modena
Modena, Italy
Not Yet Recruiting
12
Ospedale S. Gerardo
Monza, Italy
Not Yet Recruiting
13
IOV
Padova, Italy
Not Yet Recruiting
14
Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
15
Azienda Ospedaliera Universitaria Pisa
Pisa, Italy
Actively Recruiting
16
IRST (Cesena-Forlì-Meldola)
Ravenna, Italy
Not Yet Recruiting
17
Policlinico Gemelli
Rome, Italy
Not Yet Recruiting
18
Azienda Ospedaliera Ordine Mauriziano
Turin, Italy
Not Yet Recruiting
19
AOUI Verona - Policlinico "G.B. Rossi"
Verona, Italy
Not Yet Recruiting
Research Team
M
Monica Niger, MD
CONTACT
F
Federico Nichetti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here