Actively Recruiting
A Prospective Multi-center Trial Evaluating Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
Led by Guangdong Provincial People's Hospital · Updated on 2024-12-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
T
Tianjin Third Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of pressurized intraperitoneal aerosol chemotherapy (PIPAC) delivered through a new nebulized drug delivery system (NDDS) for patients with peritoneal metastatic adenocarcinoma (PMA) originating from gastric, colorectal, appendiceal, or ovarian cancers. This prospective, multi-center, single-arm trial aims to provide data especially for Asian populations, as current evidence primarily comes from Western countries. The study focuses on assessing adverse events, device performance, pain levels, and quality of life, along with other important cancer-related outcomes. The novel NDDS includes a central computer, high-pressure pump, spray nozzle, and safety features to deliver chemotherapy drugs under a standard pressure during PIPAC. Patients receive three cycles of PIPAC combined with systemic chemotherapy regimens like XELOX or FOLFOX. The interval between PIPAC treatments is 4 to 6 weeks, with systemic chemotherapy timed 1 to 2 weeks apart from PIPAC. Drug choices differ based on cancer origin: doxorubicin and cisplatin for gastric or ovarian cancers, and oxaliplatin for colorectal or appendiceal cancers. Participants will be monitored through scheduled assessments including adverse events tracking within weeks after PIPAC procedures, device defect checks, daily pain scoring for one week post-treatment, and quality of life questionnaires at multiple time points. Additional evaluations during PIPAC include cancer indices, regression grading, response rates, ascites improvement, and survival measures. The study is conducted in 25 medical centers with follow-up extending up to six months post-treatment, aiming to enroll about 30 patients.
CONDITIONS
Brief Title
The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathology verified peritoneal metastatic adenocarcinoma from gastric, colorectal, appendiceal, or ovarian carcinoma
- Men and women aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- No other concurrent malignancies
- No contraindications for laparoscopic surgery
- Adequate blood counts and liver and kidney function per laboratory tests
- Life expectancy greater than 6 months
- Informed consent understood and signed
You will not qualify if you...
- Symptoms of gastrointestinal obstruction
- Fully dependent on parenteral nutrition
- Presence of decompensated ascites
- Severe abdominal infection such as peritonitis
- Extensive adhesions in the abdominal cavity
- Undergoing cytoreductive surgery or gastrointestinal resection/reconstruction
- Portal vein thrombosis
- Significant or uncontrolled medical conditions or infections
- Allergy to previous chemotherapy drugs
- Severe cardiopulmonary, liver, kidney, or blood diseases, or drug abuse
- Pregnant or breastfeeding women
- Participation in other clinical trials within the past 3 months
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive three cycles of pressurized intraperitoneal aerosol chemotherapy (PIPAC) combined with concurrent systemic chemotherapy. PIPAC procedures occur every 4 to 6 weeks, with systemic chemotherapy administered at specified intervals between PIPAC treatments.
3 PIPAC procedures with visits every 4 to 6 weeks plus systemic chemotherapy visits in between
Duration - Up to 6 months after treatment
Participants are monitored for adverse events, quality of life, and survival outcomes up to 6 months after the final PIPAC procedure.
Visits at 4 to 6 weeks after the first and second PIPAC procedures, and at 6 months after the third PIPAC procedure
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
Y
Yong Li, M.D., Ph.D.
L
Liming Yao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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