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NCT04475159

Combined Neoadjuvant Systemic and PIPAC Therapy (NASPIT) for Patients With Colorectal Peritoneal Metastasis Eligible for CRS and HIPEC: A Prospective Phase II Trial

Status unknown Phase 2 Last updated 17 July 2020
What this trial tests

Phase 2 trial testing Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Metastatic Colorectal Cancer in 50 participants. Status unknown.

Timeline
1 August 2020
Primary endpoint
1 August 2022
1 August 2023

Quick facts

Lead sponsorProf. Aviram Nissan
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date1 August 2020
Primary completion1 August 2022
Estimated completion1 August 2023

Drugs / interventions tested

Conditions studied

Sponsor

Prof. Aviram Nissan

Who can join

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

Sponsor's own description

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug-delivery system developed to deliver, effectively and safely, small doses of cytotoxic agents into peritoneal tumor deposits. It is currently used for palliation and for down-staging of patients who are non-eligible for cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC). The aim of this study is to evaluate the efficacy of PIPAC used in neoadjuvant setting to enhance the response of patients with colorectal peritoneal metastasis when combined with neoadjuvant systemic therapy for patients eligible to CRS/HIPEC prior to planned surgery.

Publications & conference data

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

  1. PIPAC for Gastrointestinal Malignancies.
    Daniel SK, Sun BJ, Lee B. · · 2023 · cited 15× · PMID 37959264 · DOI 10.3390/jcm12216799
  2. 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
  3. Is PIPAC a Treatment Option in Upper and Lower Gastrointestinal Cancer with Peritoneal Metastasis?
    Guel-Klein S, Alberto Vilchez ME, Ceelen W, Rau B, et al · · 2022 · cited 3× · PMID 35614892 · DOI 10.1159/000523901
  4. Physiological Considerations and Delivery Strategies for Targeting Tumors Through Intraperitoneal Delivery.
    Jony MJH, Ranjbar S, Prajapati R, Eslami SM, et al · · 2025 · cited 2× · PMID 40855029 · DOI 10.1007/s11095-025-03917-0

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