Effect of the administration of intraperitonel aerosolized chemotherapy in patients with unresectable peritoneal metastases from digestive, ovary and peritoneal origin

CLINICAL TRIAL PHASE IIB ON THE TREATMENT WITH PIPAC (PRESSURIZED INTRAPERITONEAL AEROSOL CHEMOTHERAPY) IN PATIENTS WITH NON-RESECTABLE PERITONEAL CARCINOMATOSIS

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001417-36-ES

Enrollment

Registered

2021-06-08

Start date

2021-08-02

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient presenting unresectable peritoneal metastases from digestive system, ovary or primary peritoneal origin MedDRA version: 21.1 Level: PT Classification code 10051676 Term: Metastases to peritoneum System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Cisplatino Pharmacia 100 ml Product Name: CISPLATINO Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin CAS Number: 15663-27-1 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 18 and 75 years - Diagnosis of unresectable peritoneal carcinomatosis - (Decided in tumor board) - Diagnosis of peritoneal carcinomatosis of the following origins: - High-grade serous ovarian carcinoma unresponsive to 2 lines of intravenous chemotherapy - Colon adenocarcinoma - Gastric adenocarcinoma - Epithelioid variety of peritoneal mesothelioma - ECOG =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - Distant extraperitoneal metastases - Life expectancy 2 - Contraindication of administration of the chemotherapeutic drug contained in the specific protocol for that tumor - Previous abdominal surgery in the 4 weeks prior to administration - Patients with concomitant administration of immunosuppressants - Pregnant or breastfeeding patients - Decompensated ascites (> 3000 c.c.)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this project is to establish the efficacy of the administration of PIPAC in patients with unresectable peritoneal metastases of gynecological, digestive or primary peritoneal origin, in terms of tumor regression objectified by biopsies, measurement of PCI and clinical parameters (CT and symptoms ). A reduction of the mean PGRS score from 2.04 to 1.56 or in 67% of patients is expected.;Secondary Objective: To determine the quality of life, overall survival and the safety profile of the therapy in terms of morbidity and mortality associated with the procedure. ;Primary end point(s): To establish the efficacy in terms of histological tumor regression using the PGRS score of the administration of pressurized intraperitoneal chemotherapy in patients;Timepoint(s) of evaluation of this end point: After each PIPAC procedure (every 4-6 weeks)	—

Measure

Time frame

Main Objective: The main objective of this project is to establish the efficacy of the administration of PIPAC in patients with unresectable peritoneal metastases of gynecological, digestive or primary peritoneal origin, in terms of tumor regression objectified by biopsies, measurement of PCI and clinical parameters (CT and symptoms ). A reduction of the mean PGRS score from 2.04 to 1.56 or in 67% of patients is expected.;Secondary Objective: To determine the quality of life, overall survival and the safety profile of the therapy in terms of morbidity and mortality associated with the procedure. ;Primary end point(s): To establish the efficacy in terms of histological tumor regression using the PGRS score of the administration of pressurized intraperitoneal chemotherapy in patients;Timepoint(s) of evaluation of this end point: After each PIPAC procedure (every 4-6 weeks)

—

Secondary

Measure	Time frame
Secondary end point(s): - Evaluate quality of life using a questionnaire approved for this purpose - Evaluate Overall survival - Evaluate postoperative morbidity - Evaluate adverse events;Timepoint(s) of evaluation of this end point: After each PIPAC procedure (every 4-6 weeks)	—

Countries

Spain

Contacts

Public ContactDEPARTMENT OF SURGERY

HOSPITAL CLINICO UNIVERSITARIO

esogasper@gmail.com34961973500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026