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clinical / clinicalNAPOLI trials, liposomal irinotecan, second-line PDAC therapy

Andrea Wang-Gillam

王吉兰

MD, PhD

🏢Washington University School of Medicine in St. Louis / Siteman Cancer Center(圣路易斯华盛顿大学医学院 / 西特曼癌症中心)🌐USA

Professor of Medicine, Division of Oncology; Co-Leader, GI Cancer Disease Group, Siteman Cancer Center肿瘤学部医学教授;西特曼癌症中心GI癌症疾病组联合主任

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Andrea Wang-Gillam, MD, PhD is Professor of Medicine in the Division of Oncology at Washington University School of Medicine in St. Louis and Co-Leader of the GI Cancer Disease Group at Siteman Cancer Center. She is internationally recognized as a leading clinical investigator in pancreatic cancer, with particular expertise in the development of liposomal irinotecan (nal-IRI, also known as irinotecan liposome injection or ONIVYDE) and the NAPOLI series of clinical trials. Dr. Wang-Gillam was a key collaborator and co-investigator on the NAPOLI-1 trial (published in Lancet 2016), the pivotal phase III study demonstrating that liposomal irinotecan plus 5-FU/leucovorin significantly improved overall survival compared with 5-FU/leucovorin alone in patients with metastatic PDAC who had progressed after gemcitabine-based therapy — establishing nal-IRI/5-FU as the standard-of-care second-line regimen and leading to FDA approval in 2015. She subsequently contributed to the NAPOLI-3 trial, a phase III study evaluating NALIRIFOX (nal-IRI plus oxaliplatin and 5-FU/leucovorin) versus nab-paclitaxel plus gemcitabine as first-line therapy for metastatic PDAC, which demonstrated improved OS for NALIRIFOX (published NEJM 2023). Dr. Wang-Gillam has also contributed to clinical trial programs targeting the PDAC tumor microenvironment, combination immunotherapy strategies, and novel drug delivery approaches. She has a PhD in chemistry and brings a translational drug chemistry perspective to her clinical research, enabling unique insights into formulation pharmacology. She has authored more than 130 peer-reviewed publications.

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🧪Research Fields 研究领域

NAPOLI-1 and NAPOLI-3 Trials — Liposomal Irinotecan (nal-IRI) in PDACNAPOLI-1和NAPOLI-3试验——脂质体伊立替康在PDAC中的应用
Second-Line and Later-Line Systemic Therapy for Metastatic PDAC转移性PDAC的二线和后线系统治疗
Novel Chemotherapy Formulations and Drug Delivery in Pancreatic Cancer胰腺癌新型化疗制剂与药物递送
Tumor Microenvironment and Immunotherapy Combinations in PDACPDAC肿瘤微环境与免疫治疗联合方案
GI Cancer Clinical Trials — Pancreatic, Biliary, and Colorectal ProgramsGI癌症临床试验——胰腺、胆道和结直肠项目

🎓Key Contributions 主要贡献

NAPOLI-1 Trial — Establishing Liposomal Irinotecan as Standard Second-Line Therapy in PDAC

Contributed as a key co-investigator to the phase III NAPOLI-1 trial (Lancet 2016; n=417) demonstrating that nal-IRI plus 5-FU/leucovorin improved median OS (6.1 vs. 4.2 months; HR 0.67) versus 5-FU/leucovorin alone in gemcitabine-refractory metastatic PDAC — the pivotal study leading to FDA approval of ONIVYDE in 2015 and establishing the first randomized evidence-based second-line standard of care for PDAC.

NAPOLI-3 — NALIRIFOX as Improved First-Line Regimen for Metastatic PDAC

Contributed to the NAPOLI-3 phase III trial (NEJM 2023) comparing NALIRIFOX (nal-IRI + oxaliplatin + 5-FU/leucovorin) versus nab-paclitaxel + gemcitabine in first-line metastatic PDAC, demonstrating significantly improved OS (11.1 vs. 9.2 months; HR 0.83) and PFS for NALIRIFOX — one of the most important first-line PDAC advances in a decade and potentially establishing a new treatment option at the frontline.

Clinical Pharmacology and Drug Delivery of Liposomal Chemotherapy in PDAC

Leveraged her PhD chemistry background to contribute translational research characterizing the pharmacokinetics, intratumoral drug delivery advantages, and mechanism of activity of nal-IRI compared with conventional irinotecan in PDAC, including the ability of liposomal encapsulation to achieve prolonged tumor tissue drug exposure and avoid peak plasma toxicity limitations.

PDAC Tumor Microenvironment — Combination Strategies with Immunotherapy and Stroma Targeting

Contributed to clinical development of combination strategies pairing liposomal irinotecan or other chemotherapy backbones with immune checkpoint inhibitors, anti-stroma agents (including hyaluronidase), and other novel mechanisms, with the goal of exploiting immunogenic cell death and stroma disruption to sensitize PDAC to immunotherapy.

Representative Works 代表性著作

[1]

Liposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer (NAPOLI-1)

The Lancet (2016)

Phase III NAPOLI-1 trial establishing nal-IRI plus 5-FU/leucovorin as the standard second-line regimen in gemcitabine-refractory metastatic PDAC, leading to FDA approval of ONIVYDE.

[2]

Irinotecan Liposome Injection (ONIVYDE) plus 5-Fluorouracil/Leucovorin versus Nab-Paclitaxel plus Gemcitabine in First-Line Metastatic PDAC (NAPOLI-3)

New England Journal of Medicine (2023)

Phase III NAPOLI-3 trial demonstrating improved OS with NALIRIFOX vs. nab-paclitaxel/gemcitabine as first-line therapy for metastatic PDAC.

[3]

Combination therapy with a liposomal irinotecan regimen in early-phase trials for advanced pancreatic cancer

Cancer Chemotherapy and Pharmacology (2018)

Translational pharmacological study examining nal-IRI combination strategies in pancreatic cancer models and early-phase clinical settings.

[4]

Phase 1 clinical trial of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer

Investigational New Drugs (2012)

Phase I study evaluating the tyrosine kinase inhibitor masitinib combined with gemcitabine in advanced PDAC.

🏆Awards & Recognition 奖项与荣誉

🏆Washington University School of Medicine Dean's Award for Excellence in Clinical Research
🏆Pancreatic Cancer Action Network Career Development Award
🏆ASCO Conquer Cancer Merit Award
🏆National Pancreatic Cancer Foundation Research Award
🏆Siteman Cancer Center SPORE Investigator Award

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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