OncoMatch/Clinical Trials/NCT04329494
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Is NCT04329494 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for clinical stage iv gastric cancer ajcc v8.
Treatment: Cisplatin · Doxorubicin · Fluorouracil · Intraperitoneal Chemotherapy · Irinotecan · Leucovorin · Mitomycin · Oxaliplatin — This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Colorectal Cancer
Tumor Agnostic
Ovarian Cancer
Disease stage
Required: Stage IV, IVA, IVB, IVC (AJCC v8)
Metastatic disease required
Stage IV, IVA, IVB, IVC (AJCC v8); peritoneal carcinomatosis
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status (PS) ≤ 2
Prior therapy
Must have received: chemotherapy
Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2)
Must have received: systemic chemotherapy — first-line
For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy
Cannot have received: anthracycline (doxorubicin, daunorubicin, epirubicin, idarubicin)
Exception: maximum cumulative doses
Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones (Arm 1: ovarian, uterine, gastric)
Cannot have received: intra-abdominal aerosol chemotherapy
Prior intra-abdominal aerosol chemotherapy (Arm 2 and 3: colorectal/appendiceal)
Lab requirements
Blood counts
ANC ≥ 1500/mm³; Platelets ≥ 100,000/mm³; Hemoglobin ≥ 9 g/dl
Kidney function
Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 40 ml/min (Cockcroft-Gault)
Liver function
Serum total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases or chronic liver disease); Alkaline phosphatase ≤ 2 x ULN
ANC ≥ 1500/mm³; Platelets ≥ 100,000/mm³; Hemoglobin ≥ 9 g/dl; Serum total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases or chronic liver disease); Alkaline phosphatase ≤ 2 x ULN; Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 40 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Mayo Clinic in Florida · Jacksonville, Florida
- Northwell Health Cancer Institute at Huntington · Greenlawn, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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