OncoMatch/Clinical Trials/NCT06037980
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
Is NCT06037980 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Gemcitabine and Nab paclitaxel for biliary tract cancer.
Treatment: Gemcitabine · Nab paclitaxel · Cisplatin · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Biomarker criteria
Excluded: DPYD complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
No presence of complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency with DPYD gene testing mandatory at screening as per national guidelines
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Previous or concurrent systemic (eg cytotoxic or targeted or other experimental drugs) therapy for BTC
Cannot have received: surgery
Exception: Incidentally Detected Gallbladder Carcinoma (IGBC) after simple cholecystectomy with indication for radical second surgery (>pT2) or newly diagnosed GBC
No prior tumor resection for BTC. Prior surgery or locoregional therapy for BTC
Cannot have received: locoregional therapy
Prior surgery or locoregional therapy for BTC
Cannot have received: antineoplastic treatment including radiotherapy
Any other concurrent antineoplastic treatment including radiotherapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L; hemoglobin ≥ 9 g/dl (prior transfusions allowed)
Kidney function
serum creatinine ≤ 1.5 x institutional ULN and calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min
Liver function
Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL (exceptions: 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 baseline hematologic function... Adequate liver function... Adequate renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify