NCT06003998 (INTERACT-II) is a Phase 2 clinical trial of Irinotecan in Colorectal Cancer, sponsored by Catharina Ziekenhuis Eindhoven.

Who is sponsoring NCT06003998?

NCT06003998 is sponsored by Catharina Ziekenhuis Eindhoven.

What drugs are being tested in NCT06003998?

Interventions in NCT06003998: Irinotecan, FOLFOX regimen, Bevacizumab.

What condition does NCT06003998 study?

NCT06003998 studies Colorectal Cancer, Peritoneal Metastases.

Is NCT06003998 still recruiting?

NCT06003998 is currently status unknown. Last updated 22 August 2023.

Last reviewed 2023-08-22 · How we verify

NCT06003998: INTERACT-II

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

Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

Status unknown Phase 2 Last updated 22 August 2023

What this trial tests

Phase 2 trial testing Irinotecan in Colorectal Cancer in 85 participants. Status unknown.

Timeline

27 December 2022

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	Catharina Ziekenhuis Eindhoven
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	85
Start date	27 December 2022
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	2 locations across Netherlands

Drugs / interventions tested

Irinotecan (irinotecan) — full drug profile →
FOLFOX regimen — full drug profile →
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Peritoneal Metastases — all drugs for Peritoneal Metastases →

Sponsor

Catharina Ziekenhuis Eindhoven — full company profile →

Who can join

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

Sponsor's own description

The rationale of the current study is that the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and might result in an increased overall and progression free survival in patients with unresectable colorectal peritoneal metastases. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients with unresectable colorectal peritoneal metastases. Secondary objectives are to assess the progression-free survival, toxicity profile, patient reported outcomes, costs, tumor response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan and SN-38. This is a single-arm, open-label, phase II study and patients will receive intraperitoneal irinotecan (75 mg) in combination with modified FOLFOX4 + bevacizumab.

Publications & conference data

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

Population pharmacokinetics of intraperitoneal irinotecan and SN-38 in patients with peritoneal metastases from colorectal origin.
Rietveld PCS, Sassen SDT, Guchelaar NAD, van Eerden RAG, et al · · 2024 · cited 5× · PMID 38634204 · DOI 10.1002/psp4.13136
Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase II, INTERACT-II trial.
van de Vlasakker VCJ, Guchelaar NAD, van den Heuvel TBM, Lurvink RJ, et al · · 2024 · cited 5× · PMID 38238055 · DOI 10.1136/bmjopen-2023-077667
Targeting the DNA damage response prevents regrowth of colorectal peritoneal metastasis-derived organoids following treatment with mitomycin C.
van Megesen K, Stefan A, Kieboom M, Amico R, et al · · 2026 · PMID 41491222 · DOI 10.1038/s41416-025-03310-z
Hydrogel-Based intraperitoneal drug delivery platforms for peritoneal metastasis: strategies, advances, and prospects.
Chen X, Wei Y, Chen X, Zheng L, et al · · 2026 · PMID 41414871 · DOI 10.1080/10717544.2025.2576199

Verify or expand the search:

Other trials of Irinotecan

Trials testing the same drug.

NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07487896 — A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esopha · Phase 3 · not yet recruiting
NCT07474727 — A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer · Phase 2 · not yet recruiting
NCT07381764 — ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected M · Phase 2 · not yet recruiting

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Catharina Ziekenhuis Eindhoven trials

Trials by the same sponsor.

NCT07314138 — Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronar · NA · not yet recruiting
NCT06768060 — Mindfulness-based Intervention Prior to External Cephalic Version · NA · recruiting
NCT06574867 — Evaluation of the viQtor Monitoring Solution on Surgical Wards · recruiting
NCT06374836 — The Contractile Response of the Thoracic Aorta to Vasoactive Substances · completed
NCT06401291 — Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries · NA · 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 NCT06003998 (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 Catharina Ziekenhuis Eindhoven
Last refreshed: 22 August 2023

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/NCT06003998.

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