PIPAC in Gastric Peritoneal Metastasis (NCT07517419) | Clinical Trial Compass
By InvitationPhase 2
PIPAC in Gastric Peritoneal Metastasis
Hong Kong30 participantsStarted 2021-10-11
Plain-language summary
This is a pilot study aiming at evaluating the effects of PIPAC with Doxorubicin + Cisplastin on patients with PM of gastric cancer. All patients who are diagnosed with gastric cancer with peritoneal metastases in the Prince of Wales Hospital (PWH), HK will be screened for eligibility.
There are two aims for this study:
1. To evaluate safety and efficacy of the procedure together with postoperative outcomes and long term overall and progression free survival.
2. Aim at obtaining tissue samples for molecular analysis and for potential tissue organoids and biobank.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Patients age \>= 18, \<= 80 years old
ā. Performance status (WHO) \<=2
ā. Histologically evidenced synchronous PM of gastric adenocarcinoma cancer
ā. Peritoneal Cancer Index (PCI) score \> 8, or \<=8 and patient not fit for cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CRS + HIPEC)
ā. Patients with isolated ovarian metastasis could be included
ā. White blood cells \>3.5000/mm3; neutrophils \> 1.500/mm3; platelets \>100,000/mm3
ā. Creatinine \<1.5mg/dL and creatinine clearance \>60ml/min and serum total bilirubin \<2mg/dL
ā. Ability to give written consent prior to commencement of treatment
Exclusion criteria
ā. Extraperitoneal metastases including liver metastases and malignant pleural effusion. The presence of suspicious retroperitoneal lymph nodes is not an exclusion criterium.
ā. Patients with adenocarcinoma of Siewart I
ā. Bowel obstruction, not tolerating oral diet
ā. HER2+++ tumor with indicated for Trastuzumab therapy
ā. Any laparotomy during 3 months before inclusion. (Laparoscopy is not an exclusion criterium)
What they're measuring
1
Mortality
Timeframe: From recruitment up to five years / death