NCT06743867 The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma
| NCT ID | NCT06743867 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangdong Provincial People's Hospital |
| Condition | Peritoneal Carcinoma Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-11 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-12-11 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Primary endpoints include adverse events (AEs) and serious AEs, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, incidences of device defects, postoperative pain scores evaluated using the Visual Analogue Scale / Score (VAS), and quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). Secondary endpoints include the intra-abdominal peritoneal cancer index (PCI), peritoneal regression grading score (PRGS), objective response rate (including partial response (PR) and complete response (CR)), improvement in ascites, conversion rate (patients proceeding to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) following initial PIPAC treatments), progression-free survival (PFS), and overall survival (OS).
Eligibility Criteria
Inclusion Criteria: 1. Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma; 2. Applicable to individuals of either sex, aged between 18 and 75 years; 3. Eastern Cooperative Oncology Group (ECOG) scale ≤ 2; 4. Absence of other concurrent malignancies; 5. Without contraindications for laparoscopic surgery; 6. 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 aspartate aminotransferase ≤ 2.5 ×ULN, serum creatinine ≤ 1.5 ×ULN; 7. Life expectancy \> 6 months; 8. Informed consent understood and signed. Exclusion Criteria: 1. Presenting symptoms of gastrointestinal obstruction; 2. Fully reliant on parenteral nutrition; 3. Exhibiting decompensated ascites; 4. Suffering from severe abdominal infection (indications of peritonitis); 5. Characterized by extensive adhesions in the abdominal cavity; 6. Concurrently undergoing cytoreductive surgery (CRS) or gastrointestinal tract resection and reconstruction procedures; 7. With portal vein thrombosis; 8. Concurrently, individuals with significant or unmanaged medical conditions or infections (including atrial fibrillation, angina, cardiac dysfunction, ejection fraction \< 50%, refractory hypertension etc.); 9. Previous chemotherapeutic drugs allergy; 10. Severe cardiopulmonary, hepatonephric, hematologic, and metal diseases, or drug abuse; 11. Pregnancy or lactating women; 12. Engage in additional clinical trials within three months preceding recruitment; 13. Other conditions: patients are inappropriately included as determined by researchers.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06743867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Peritoneal Carcinoma Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06743867 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06743867 currently recruiting?
Yes, NCT06743867 is actively recruiting participants. Contact the research team at liyong@gdph.org.cn for enrollment information.
Where is the NCT06743867 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06743867 clinical trial?
NCT06743867 is sponsored by Guangdong Provincial People's Hospital. The trial plans to enroll 30 participants.