NCT04088786 is a Phase 1 clinical trial of nanoliposomal irinotecan in Peritoneal Cancer, sponsored by Stony Brook University.

Who is sponsoring NCT04088786?

NCT04088786 is sponsored by Stony Brook University.

What drugs are being tested in NCT04088786?

Interventions in NCT04088786: nanoliposomal irinotecan.

What condition does NCT04088786 study?

NCT04088786 studies Peritoneal Cancer, Pseudomyxoma Peritonei, Mucinous Adenocarcinoma, Mucinous Tumor, Colorectal Cancer, Gastric Cancer, Primary Peritoneal Carcinoma, Mesothelioma.

Is NCT04088786 still recruiting?

NCT04088786 is currently completed. Last updated 6 May 2022.

Last reviewed 2022-05-06 · How we verify

NCT04088786

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Trial HIPEC With Nal-irinotecan

Completed Phase 1 Last updated 6 May 2022

What this trial tests

Phase 1 trial testing nanoliposomal irinotecan in Peritoneal Cancer in 18 participants. Completed in 14 April 2022.

Timeline

22 October 2019

Primary endpoint
11 October 2021

14 April 2022

Quick facts

Lead sponsor	Stony Brook University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	22 October 2019
Primary completion	11 October 2021
Estimated completion	14 April 2022
Sites	2 locations across United States

Drugs / interventions tested

nanoliposomal irinotecan — full drug profile →

Conditions studied

Peritoneal Cancer — all drugs for Peritoneal Cancer →
Pseudomyxoma Peritonei — all drugs for Pseudomyxoma Peritonei →
Mucinous Adenocarcinoma — all drugs for Mucinous Adenocarcinoma →
Mucinous Tumor — all drugs for Mucinous Tumor →

Sponsor

Stony Brook University

Who can join

18 and older, any sex, with Peritoneal Cancer or Pseudomyxoma Peritonei. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Mucin in cancer: a stealth cloak for cancer cells.
Wi DH, Cha JH, Jung YS. · · 2021 · cited 34× · PMID 34154702
Current Trends in Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Peritoneal Disease from Appendiceal and Colorectal Malignancies.
Harper MM, Kim J, Pandalai PK. · · 2022 · cited 14× · PMID 35628966 · DOI 10.3390/jcm11102840
A Multicenter Phase 1 Trial Evaluating Nanoliposomal Irinotecan for Heated Intraperitoneal Chemotherapy Combined with Cytoreductive Surgery for Patients with Peritoneal Surface Disease.
Choi M, Harper MM, Pandalai PK, Abdel-Misih SRZ, et al · · 2023 · cited 8× · PMID 36344711 · DOI 10.1245/s10434-022-12723-6
Society of Surgical Oncology SSO 2022 - International Conference on Surgical Cancer Care.
· 2022 · cited 2× · PMID 35469114 · DOI 10.1245/s10434-022-11828-2

Verify or expand the search:

Other trials of nanoliposomal irinotecan

Trials testing the same drug.

NCT05363007 — Spleen Irradiation With Nanoliposomal Irinotecan Plus 5-FU and Leucovorin in Metastatic Pancreatic Adenocarcinoma · Phase 2 · unknown
NCT03712397 — Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy · Phase 2 · completed
NCT02022644 — Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma · Phase 1 · completed

Other recruiting trials for Peritoneal Cancer

Currently open trials in the same condition.

NCT06969833 — Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma · NA · recruiting
NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
NCT06735326 — Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer · Phase 2 · recruiting
NCT07022535 — Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer · Phase 2 · recruiting
NCT06290193 — Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery · Phase 2 · recruiting

Other Stony Brook University trials

Trials by the same sponsor.

NCT07478250 — First Responder Safety Training (FiRST) · NA · not yet recruiting
NCT07076342 — The Role of mGluR5 in CBT-I · Phase 4 · recruiting
NCT07009691 — Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS · NA · recruiting
NCT07114900 — Randomized Controlled Physical Activity App Intervention for Black Women · Phase 3 · active not recruiting
NCT05245227 — Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04088786 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stony Brook University
Last refreshed: 6 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04088786.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing