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AzTrials

Biliary Tract CancerPhase 2/3PURITYNCT06037980

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 2/3 study testing Gemcitabine, Nab paclitaxel and Cisplatin in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Gruppo Oncologico del Nord-Ovest at 19 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer, Cholangiocarcinoma
What is being tested?
Gemcitabine, Nab paclitaxel and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
19 sitesItaly
Study dates
7 Nov 2023to Jan 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.
  • Female and male patients ≥18 years and <75 years.
  • Histologically or cytologically confirmed non metastatic resectable carcinoma of biliary tract (BTC), including gallbladder carcinoma (GBC), intrahepatic, periperihilar or distal Cholangiocarcinoma (CCA). Mixed tumor entities with hepatocellular carcinoma and ampullary cancers are excluded.
  • Availability of a tumoral sample
  • ECOG performance status of 0-1.
  • No prior tumor resection for BTC.
Show all 37Show fewer
  • Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax and PET scan.
  • Technically resectable BTC as per local Multidisciplinary Team (MDT) assessment, including a core team with at least one medical oncologist, one surgeon, one radiologist, one endoscopist/gastroenterologist and one pathologist, all with expertise > 3 years on biliary tract cancer and hepatobiliary oncology.
  • High risk for recurrence defined as the presence of at least one of the following risk features, as evaluated at baseline (pre-surgery):
  • For cholangiocarcinoma:
  • Suspected or definite locoregional lymph node involvement (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 MDT 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.
  • For GBC:
  • Incidentally Detected Gallbladder Carcinoma (IGBC) after simple cholecystectomy with indication for radical second surgery (>pT2) or newly diagnosed GBC.
  • Estimated life expectancy > 3 months.
  • Adequate baseline hematologic function characterized by the following at screening:
  • ANC ≥ 1.5 × 109/L
  • platelets ≥ 100 × 109/L
  • hemoglobin ≥ 9 g/dl. Note: prior transfusions for patients with low hemoglobin are allowed.
  • Adequate liver function characterized by the following at screening:
  • Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL. Note: Subjects with Serum total bilirubin ≥ 1.5 × ULN and conjugated bilirubin ≤ ULN or < 40% of total bilirubin are allowed.
  • Serum transaminases (AST and/or ALT) < 3 x ULN.
  • Adequate renal function, i.e. serum creatinine ≤ 1.5 x institutional ULN and calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min
  • Adequate coagulation functions as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).
  • No presence of complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency with DPYD gene testing mandatory at screening as per national guidelines
  • Females of childbearing potential must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods, as defined in APPENDIX V of the full protocol, during the treatment period and for at least 7 months after the last administration of study treatments.
  • Males must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods, as defined in APPENDIX V of the full protocol.
  • Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause.
  • A participant must agree not to donate eggs/sperm for future use for the purposes of assisted reproduction during the study and for a period of 7 months after receiving the last dose of study treatment. Female and male participants should consider preservation of eggs/sperm prior to study treatment as anti-cancer treatments may impair fertility.

Who cannot join

  • Known allergy or hypersensitivity to any of the study drugs.
  • Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer.
  • Locally unresectable tumor according to local MDT (including radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow, and sufficient future liver remnant).
  • Evidence of distant metastases at any site.
  • Tumors requiring multi-step surgical procedures such as two-stage hepatectomy or Associating Liver Partition and Portal vein Ligation for Staged hepatectomy (ALPPS) due to liver volumetry-based assessment of anticipated inadequate future liver remnant.
  • Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic decompensation in the year before enrolment.
Show all 18Show fewer
  • Know active uncontrolled hepatitis B or hepatitis C. Patients with a past or resolved HBV infection are eligible. Patients with chronic disease controlled by antiviral therapy or requiring prophylactic treatment are eligible.
  • Chronic or current active infectious disease requiring systemic antibiotics or antifungal treatment within 2 weeks prior to enrollment.
  • Known uncontrolled HIV infection. HIV-positive patients are eligible if their CD4+ cell count amounts to 300 cells per μL or more; HIV viral load must be undetectable per standard of care assay, and they must be compliant with antiretroviral treatment.
  • Pregnant or breast-feeding patient, or patient is planning to become pregnant within 7 months after the end of treatment.
  • Any other concurrent antineoplastic treatment including radiotherapy.
  • Previous or concurrent systemic (eg cytotoxic or targeted or other experimental drugs) therapy for BTC.
  • Prior surgery or locoregional therapy for BTC.
  • Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last three months, significant arrhythmia).
  • Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent.
  • Any serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial.
  • Presence of complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency with DPYD gene testing mandatory at screening as per national guidelines.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Monica Niger, MD contact

02 2390 2919

monica.niger@istitutotumori.mi.it

19 sites in 1 country

Italy19 sites, 19 recruiting

  • Ospedali Riuniti di Ancona

    Ancona

    Rossana Berardi

    Not yet recruiting

  • ASST Papa Giovanni XXIII

    Bergamo

    Stefania Mosconi

    Not yet recruiting

  • Oncologia Medica Policlinico Sant'Orsola - Malpighi

    Bologna

    Giovanni Brandi

    Not yet recruiting

  • ASST Spedali Civili

    Brescia

    Giuseppina Arcangeli

    Not yet recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo

    Elena Fea

    Not yet recruiting

  • IRST Dino Amadori

    Meldola

    Ilario Giovanni Rapposelli

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Niger, MD, 02 23902919, monica.niger@istitutotumori.mi.it

    Federica Palermo, 02 2390 3835, federica.palermo@istitutotumori.mi.it

    Recruiting

  • Humanitas Cancer Center

    Milan

    Lorenza Rimassa

    Not yet recruiting

  • Ospedale Niguarda Cancer Center

    Milan

    Salvatore Siena

    Not yet recruiting

  • Ospedale San Raffaele

    Milan

    Andrea Casadei Gardini

    Not yet recruiting

  • Università di Modena

    Modena

    Massimilano Salati

    Not yet recruiting

  • Ospedale S. Gerardo

    Monza

    Raffaella Longarini

    Not yet recruiting

  • IOV

    Padova

    Francesca Bergamo

    Not yet recruiting

  • Policlinico San Matteo

    Pavia

    Salvatore Corallo

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Pisa

    Pisa

    Lorenzo Fornaro

    Recruiting

  • IRST (Cesena-Forlì-Meldola)

    Ravenna

    Stefano Tamberi

    Not yet recruiting

  • Policlinico Gemelli

    Rome

    Lisa Salvatore

    Not yet recruiting

  • Azienda Ospedaliera Ordine Mauriziano

    Turin

    Massimo Di Maio

    Not yet recruiting

  • AOUI Verona - Policlinico "G.B. Rossi"

    Verona

    Davide Melisi

    Not yet recruiting

Other trials in Italy

About this study

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

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.

Read the 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.
  1. For GBC:
  • Incidentally Detected Gallbladder Carcinoma (IGBC) After Simple Cholecystectomy with indication for radical second surgery (>pT2) or newly diagnosed GBC.
Being tested
Gemcitabine, Nab paclitaxel, Cisplatin, Curative Surgery, Capecitabine
Keywords
Biliary Tract Cancers, Cholangiocarcinoma, Neoadjuvant Chemotherapy, Cisplatin Gemcitabine Nabpaclitaxel
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

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

  • Nab paclitaxelDrug

    Also called Abraxane

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

  • CisplatinDrug

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

  • Curative SurgeryProcedure or surgery

    Curative surgery on primary tumor

  • CapecitabineDrug

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

Study groups in NCT06037980
Study groupRoleWhat they receive
Preoperative chemotherapyExperimentalTriplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment followed by surgery and adjuvant chemotherapy
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Cisplatin; Procedure: Curative Surgery; Drug: Capecitabine
Upfront surgeryActive comparatorStandard upfront surgery and adjuvant chemotherapy
Receives: Procedure: Curative Surgery; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-month progression-free survival (PFS) rate

    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).

    Measured: 12 months

  2. median PFS

    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).

    Measured: From date of randomization until the date of first documented progression (as assessed by radiological evaluation and clinical examination) or date of death from any cause, whichever came first, assessed up to 120 months

Secondary outcomes (11)

  1. Median event free survival

    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.

    Measured: from date of randomization to disease progression that precludes definitive surgery, treatment discontinuation for any reason, post-resection recurrence, diagnosis of second cancer, or death from any cause, assessed up to 120 months

  2. Median relapse free survival

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

    Measured: from date of surgery to date of disease recurrence or date of death, whichever came first, in patients who undergo surgery with curative intent, assessed up to 120 months.

  3. Median Overall survival

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

    Measured: from date of randomization to date of death (or last follow up for alive patients), assessed up to 120 months.

  4. R0 resection rate

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

    Measured: At surgery

  5. R0+R1 resection rate

    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.

    Measured: At surgery

  6. Quality of life EORTC QLQ-C30 scores

    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.

    Measured: Quality of life questionnaires will be compiled during screening (28 days before randomisation) and at restaging before (week 8 to 10 after randomisation) and after surgery (week 6 to 16 after surgery)

  7. Quality of life BIL21 scores

    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.

    Measured: Quality of life questionnaires will be compiled during screening (28 days before randomisation) and at restaging before (week 8 to 10 after randomisation) and after surgery (week 6 to 16 after surgery)

  8. Overall response rate

    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.

    Measured: At radiological evaluation as performed at restaging before surgery (week 8 to 10 after randomisation)

  9. Resectability rate of primary tumor

    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.

    Measured: Resectability rate will be assessed before surgery (after the 3 cycles of neoadjuvant chemotherapy for the experimental treatment arm)

  10. Toxicity rates

    .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).

    Measured: Through study completion, an average of 1 year for each patient

  11. Perioperative morbidity and mortality

    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.

    Measured: At surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start7 Nov 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, open-label, multicenter, randomized phase II-III study
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06037980
Sponsor's protocol ID
PURITY
Acronym
PURITY
Status last verified
Sep 2026
First submitted
9 Aug 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yadav S, Xie H, Bin-Riaz I, Sharma P, Durani U, Goyal G, Borah B, Borad MJ, Smoot RL, Roberts LR, Go RS, McWilliams RR, Mahipal A. Neoadjuvant vs. adjuvant chemotherapy for cholangiocarcinoma: A propensity score matched analysis. Eur J Surg Oncol. 2019 Aug;45(8):1432-1438. doi: 10.1016/j.ejso.2019.03.023. Epub 2019 Mar 21.

    PubMed 30914290

  • Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.

    PubMed 30998813

  • Maithel SK, Keilson JM, Cao HST, Rupji M, Mahipal A, Lin BS, Javle MM, Cleary SP, Akce M, Switchenko JM, Rocha FG. NEO-GAP: A Single-Arm, Phase II Feasibility Trial of Neoadjuvant Gemcitabine, Cisplatin, and Nab-Paclitaxel for Resectable, High-Risk Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. 2023 Oct;30(11):6558-6566. doi: 10.1245/s10434-023-13809-5. Epub 2023 Jun 27.

    PubMed 37368098

  • Niger M, Nichetti F, Fornaro L, Pircher C, Morano F, Palermo F, Rimassa L, Pressiani T, Berardi R, Gardini AC, Sperti E, Salvatore L, Melisi D, Bergamo F, Siena S, Mosconi S, Longarini R, Arcangeli G, Corallo S, Delliponti L, Tamberi S, Fea E, Brandi G, Rapposelli IG, Salati M, Baili P, Miceli R, Ljevar S, Cavallo I, Sottotetti E, Martinetti A, Busset MDD, Sposito C, Di Bartolomeo M, Pietrantonio F, de Braud F, Mazzaferro V. 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. BMC Cancer. 2024 Apr 8;24(1):436. doi: 10.1186/s12885-024-12225-6.

    PubMed 38589856

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gemcitabine, Nab paclitaxel and Cisplatin in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Gruppo Oncologico del Nord-Ovest at 19 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monica Niger, MD (02 2390 2919, monica.niger@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month progression-free survival (PFS) rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06037980, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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