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Compares treatment options for Biliary Tract Cancer
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
ClinicalTrials.gov ID: NCT06037980
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
- Availability of a tumoral sample
- ECOG performance status of 0-1.
You likely can't join if
- 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...
- Locally unresectable tumor according to local MDT (including radiological evidence suggesting inability to resect with curative intent whilst...
- 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...
- 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.
See the full eligibility criteria
Who can 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...
- Availability of a tumoral sample
- ECOG performance status of 0-1.
- No prior tumor resection for BTC.
- 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...
- 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: people 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ancona, Italy
- Bergamo, Italy
- Bologna, Italy
- Brescia, Italy
- Cuneo, Italy
- Meldola, Italy
- Milan, Italy
- Modena, Italy
- Monza, Italy
- Padova, Italy
- Pavia, Italy
- Pisa, Italy
- Ravenna, Italy
- Rome, Italy
- Turin, Italy
- Verona, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ancona, Italy; Bergamo, Italy; Bologna, Italy; Brescia, Italy; Cuneo, Italy; Meldola, Italy and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.