Last reviewed · How we verify

NCT03732781

Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC

Completed Phase 1, PHASE2 Last updated 28 August 2025
What this trial tests

Phase 1, PHASE2 trial testing Radspherin in Peritoneal Carcinoma in 47 participants. Completed in 14 May 2025.

Timeline
27 May 2020
Primary endpoint
14 May 2025
14 May 2025

Quick facts

Lead sponsorOncoinvent Solutions AS
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment47
Start date27 May 2020
Primary completion14 May 2025
Estimated completion14 May 2025
Sites2 locations across Sweden, Norway

Drugs / interventions tested

Conditions studied

Sponsor

Oncoinvent Solutions AS — full company profile →

Who can join

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

Sponsor's own description

This is a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma following complete CRS (cytoreduction score CC-0) and HIPEC. The study consists of three different cohorts: * Dose escalation cohorts * Repeated injection cohorts * Expansion cohort

Publications & conference data

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

  1. 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
  2. Improved Formulation of <sup>224</sup>Ra-Labeled Calcium Carbonate Microparticles by Surface Layer Encapsulation and Addition of EDTMP.
    Li RG, Lindland K, Tonstad SK, Bønsdorff TB, et al · · 2021 · cited 11× · PMID 33946852 · DOI 10.3390/pharmaceutics13050634
  3. First experience with <sup>224</sup>Radium-labeled microparticles (Radspherin®) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study).
    Larsen SG, Graf W, Mariathasan AB, Sørensen O, et al · · 2023 · cited 9× · PMID 36936230 · DOI 10.3389/fmed.2023.1070362
  4. Radiation safety considerations for the use of radium-224-calciumcarbonate-microparticles in patients with peritoneal metastasis.
    Grønningsæter SR, Blakkisrud J, Selboe S, Revheim ME, et al · · 2023 · cited 5× · PMID 36844217 · DOI 10.3389/fmed.2023.1058914
  5. Effect of Intraperitoneal <sup>224</sup>Radium-Labelled Microparticles on Compartmentalized Inflammation After Cytoreductive Surgery and Hypertherm Intraperitoneal Chemotherapy.
    Thorgersen EB, Asvall J, Schjalm C, McAdam KE, et al · · 2023 · cited 1× · PMID 37574949 · DOI 10.1177/15330338231192902
  6. Experiences and Hopes Among Patients with Colorectal Carcinoma and Peritoneal Metastases Who Are Participating in an Early-Phase Clinical Trial.
    Fauske L, Bruland ØS, Holtermann A, Larsen SG. · · 2026 · PMID 41595164 · DOI 10.3390/cancers18020244

Verify or expand the search:

Other trials of Radspherin

Trials testing the same drug.

Other recruiting trials for Peritoneal Carcinoma

Currently open trials in the same condition.

Other Oncoinvent Solutions AS trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03732781.

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