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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
Phase 2 trial testing Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Metastatic Colorectal Cancer in 50 participants. Status unknown.
1 August 2022
Quick facts
| Lead sponsor | Prof. Aviram Nissan |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 August 2020 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 August 2023 |
Drugs / interventions tested
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) — full drug profile →
Conditions studied
- Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
- Peritoneal Carcinomatosis — all drugs for Peritoneal Carcinomatosis →
- Colon Adenocarcinoma — all drugs for Colon Adenocarcinoma →
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):
-
PIPAC for Gastrointestinal Malignancies.
Daniel SK, Sun BJ, Lee B. · · 2023 · cited 15× · PMID 37959264 · DOI 10.3390/jcm12216799 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04475159
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04475159 (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 Prof. Aviram Nissan
- Last refreshed: 17 July 2020
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/NCT04475159.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing