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Tests treatment safety and results for Peritoneal Carcinoma Metastatic
Official title The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
ClinicalTrials.gov ID: NCT06743867
What this study is testing
What is Pressurized Intraperitoneal Aerosol Chemotherapy?
Pressurized Intraperitoneal Aerosol Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal carcinoma metastatic.
Also referred to as Systemic chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is a prospective, multi-center, single-arm clinical trial aimed at assessing the standard pressurized intraperitoneal aerosol chemotherapy (PIPAC) utilizing a novel nebulized drug delivery system (NDDS) for patients with peritoneal metastatic adenocarcinoma (PMA) originating from gastric, colorectal, appendiceal, or ovarian cancer. The primary objectives of this study are to assess the safety and efficacy of PIPAC with the novel NDDS in the treatment of PMA.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma;
- Applicable to individuals of either sex, aged between 18 and 75 years;
- Eastern Cooperative Oncology Group (ECOG) scale ≤ 2;
- Absence of other concurrent malignancies;
- Without contraindications for laparoscopic surgery;
You likely can't join if
- Presenting symptoms of gastrointestinal obstruction;
- Fully reliant on parenteral nutrition;
- Exhibiting decompensated ascites;
- Suffering from severe abdominal infection (indications of peritonitis);
- Characterized by extensive adhesions in the abdominal cavity;
- Concurrently undergoing cytoreductive surgery (CRS) or gastrointestinal tract resection and reconstruction procedures;
See the full eligibility criteria
- Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma;
- Applicable to individuals of either sex, aged between 18 and 75 years;
- Eastern Cooperative Oncology Group (ECOG) scale ≤ 2;
- Absence of other concurrent malignancies;
- Without contraindications for laparoscopic surgery;
- Laboratory testing: blood routine examination: neutrophil count ≥ 1.5× 10\^9/L, platelet count ≥ 80 × 10\^9/L, hemoglobin ≥ 80g/L ; blood biochemistry: serum total bilirubin ≤ 1.5 ×ULN, Alanine transaminase and...
- Life expectancy \> 6 months;
- Informed consent understood and signed.
- Presenting symptoms of gastrointestinal obstruction;
- Fully reliant on parenteral nutrition;
- Exhibiting decompensated ascites;
- Suffering from severe abdominal infection (indications of peritonitis);
- Characterized by extensive adhesions in the abdominal cavity;
- Concurrently undergoing cytoreductive surgery (CRS) or gastrointestinal tract resection and reconstruction procedures;
- With portal vein thrombosis;
- Concurrently, individuals with significant or unmanaged medical conditions or infections (including atrial fibrillation, angina, cardiac dysfunction, ejection fraction \< 50%, refractory hypertension etc.);
- Previous chemotherapeutic drugs allergy;
- Severe cardiopulmonary, hepatonephric, hematologic, and metal diseases, or drug abuse;
- Pregnancy or lactating women;
- Engage in additional clinical trials within three months preceding recruitment;
- Other conditions: patients are inappropriately included as determined by researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.