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

HOSPITAL CLINICO UNIVERSITARIO0 个研究点目标入组 16 人开始时间: 2021年6月8日最近更新: 2021年8月10日

试验速览

暂无简介。

•- 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 <= 2
•- Patients in whom resective procedures or intestinal anastomoses are NOT going to be performed
•- Signature of the informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•- Distant extraperitoneal metastases
•- Life expectancy <3 months
•- Presence of intestinal obstruction
•- Severe organ or system dysfunction
•- ECOG> 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.)

发起方

HOSPITAL CLINICO UNIVERSITARIO