NCT07493421 To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
| NCT ID | NCT07493421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unidade Local de Saúde São João |
| Condition | Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-10-01 |
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.
This trial targets 20 participants in total. It began in 2026-03-01 with a primary completion date of 2027-10-01.
⚠ 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
The goal of this clinical trial is to evaluate the safety and feasibility of a combined surgical and chemotherapy approach (pancreatectomy with cytoreductive surgery and HIPEC) in patients aged 18 and older with pancreatic ductal adenocarcinoma and synchronous peritoneal metastases. The main questions it aims to answer are: Is the 90-day mortality rate for this intensive combined procedure lower than 5%? What are the postoperative morbidity and complication rates (as measured by the Clavien-Dindo classification) for these patients? How does this treatment impact the patient's quality of life 12 months after the procedure? Participants will: Complete at least 6 months of systemic chemotherapy to ensure the disease is stable or responding (biomarker CA19-9 must decline by \>20%). Undergo a major surgical procedure involving the removal of the pancreatic tumour (total Pancreatectomy or RAMPS) and any visible abdominal metastases (Cytoreductive Surgery). Receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), where heated Cisplatin and Paclitaxel are circulated in the abdominal cavity for 90 minutes during the operation. Participate in long-term follow-up to monitor recurrence-free and overall survival.
Eligibility Criteria
Inclusion Criteria: * Pancreatic adenocarcinoma * Histologically confirmed peritoneal metastasis * Excluded other sites of metastasis (except ovary) * PCI less than or equal to 6 * Age \> 18 years * ECOG performance status 0-1 * Written informed consent Exclusion Criteria: * Pregnancy * Intestinal obstruction * Renal insufficiency (GFR \< 45 ml/min)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07493421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07493421 currently recruiting?
Yes, NCT07493421 is actively recruiting participants. Contact the research team at tiago.machado@chsj.min-saude.pt for enrollment information.
Where is the NCT07493421 trial being conducted?
This trial is being conducted at Shanghai, China, Lisbon, Portugal, Porto, Portugal.
Who is sponsoring the NCT07493421 clinical trial?
NCT07493421 is sponsored by Unidade Local de Saúde São João. The trial plans to enroll 20 participants.