NCT03172416: PIPAC

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis

Active, enrolled Phase 1 Last updated 29 May 2024

What this trial tests

Phase 1 trial testing Oxaliplatin in Peritoneal Carcinomatosis in 21 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 April 2017

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	National University Hospital, Singapore
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	12 April 2017
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	3 locations across Belgium, Singapore

Drugs / interventions tested

• Oxaliplatin (Oxaliplatin) — full drug profile →
• Oxaliplatin & Nivolumab — full drug profile →

Conditions studied

• Peritoneal Carcinomatosis — all drugs for Peritoneal Carcinomatosis →

Sponsor

National University Hospital, Singapore

Who can join

21 and older, any sex, with Peritoneal Carcinomatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using an innovative concept that enhances the efficacy by taking advantage of the physical properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form. This results in a superior distribution and depth of penetration of the drug.

This research study serves to determine the safety profile and tolerability of PIPAC with oxaliplatin. It may offer a novel and effective option of treatment for patients with peritoneal carcinomatosis, who, at present have limited options involving the use of systemic chemotherapy and who suffer from poor life expectancy and poor quality of life.

To date, most trials have used PIPAC cisplatin with doxorubicin, or oxaliplatin alone, and more studies are on-going globally.

Intravenous (IV) nivolumab has been approved for the treatment of progressive gastric cancer after conventional chemotherapy. PIPAC in combination with nivolumab may have the potential to improve immune activation and response to immune checkpoint inhibition for patients with peritoneal disease.

Hence we propose an amendment to our trial protocol for the addition of a second cohort (Cohort 2) to investigate the safety and tolerability of the combination of PIPAC oxaliplatin and IV nivolumab.

Publications & conference data

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

1. Integration of Genomic Biology Into Therapeutic Strategies of Gastric Cancer Peritoneal Metastasis.
   Gwee YX, Chia DKA, So J, Ceelen W, et al · · 2022 · cited 80× · PMID 35649219 · DOI 10.1200/jco.21.02745
2. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) as an outpatient procedure.
   Graversen M, Lundell L, Fristrup C, Pfeiffer P, et al · · 2018 · cited 26× · PMID 30911669 · DOI 10.1515/pp-2018-0128
3. Study protocol: phase 1 dose escalating study of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin in peritoneal metastasis.
   Kim G, Tan HL, Chen E, Teo SC, et al · · 2018 · cited 22× · PMID 30911663 · DOI 10.1515/pp-2018-0118
4. Inflammatory Response and Toxicity After Pressurized IntraPeritoneal Aerosol Chemotherapy.
   Teixeira Farinha H, Grass F, Labgaa I, Pache B, et al · · 2018 · cited 22× · PMID 29290765 · DOI 10.7150/jca.21460
5. Safety and Efficacy of Oxaliplatin Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Colorectal and Appendiceal Cancer with Peritoneal Metastases: Results of a Multicenter Phase I Trial in the USA.
   Raoof M, Whelan RL, Sullivan KM, Ruel C, et al · · 2023 · cited 20× · PMID 37501051 · DOI 10.1245/s10434-023-13941-2
6. The emergence of pressurized intraperitoneal aerosol chemotherapy as a palliative treatment option for patients with diffuse peritoneal metastases: a narrative review.
   Lurvink RJ, Van der Speeten K, Rovers KP, de Hingh IHJT. · · 2021 · cited 18× · PMID 33968442 · DOI 10.21037/jgo-20-497
7. PIPAC for Gastrointestinal Malignancies.
   Daniel SK, Sun BJ, Lee B. · · 2023 · cited 15× · PMID 37959264 · DOI 10.3390/jcm12216799
8. 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