To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.

NCT07493421 | Recruiting

• 1 other identifier: CE-67-2026
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Pancreatic Adenocarcinoma; Peritoneal (Metastatic) Cancer

Keywords

Pancreatic Cancer; Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy; Peritoneal Metastasis; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (2)

• Mortality

  Measurement of postoperative mortality will be recorded

  In-hospital or 90 days after surgery

• Morbidity

  Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification

  In-hospital or 90 days after surgery

Secondary Outcomes (3)

• Quality of Life after the Procedure

  12 months post-surgery

• Recurrence-Free Survival

  12 months from surgery

• Overall Survival

  12 months from surgery

Study Arms (1)

Experimental arm

EXPERIMENTAL

Pancreatectomy, combined with complete cytoreduction and HIPEC

Procedure: Pancreatectomy; Procedure: Complete Cytoreduction; Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Interventions

Pancreatectomy PROCEDURE

Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours

Also known as: Total pancreatectomy, Radical Antegrade Modular Pancreatosplenectomy, RAMPS

Experimental arm

Complete Cytoreduction PROCEDURE

Resection of all macroscopic peritoneal metastases, but also the greater and lesser omentum, the round ligament of the liver, the appendix and the ovaries, in case of female patients

Also known as: CRS

Experimental arm

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) OTHER

HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Intestinal obstruction
• Renal insufficiency (GFR \< 45 ml/min)

Sponsors & Collaborators

• Unidade Local de Saúde São João: lead
• University Medical Center Hamburg-Eppendorf (UKE): collaborator
• The Champalimaud Centre, Lisbon, Portugal: collaborator
• Leiden University Medical Center: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (3)

Zhongshan Hospital, Fudan University

Shanghai, shangaiShanghai Municipality, 200000, China

NOT YET RECRUITING

Botton/Chamaplimaud Pancreatic cancer center

Lisbon, Lisbon District, 1400-038, Portugal

NOT YET RECRUITING

ULS São João

Porto, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Pancreatic Neoplasms; Peritoneal Neoplasms

Interventions

Pancreatectomy; Architectural Accessibility; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Facility Design and Construction; Architecture; Technology, Industry, and Agriculture; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Central Study Contacts

Tiago Bouça-Machado, MD

CONTACT

+351 225 512 100; tiago.machado@chsj.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective, Single-Arm, Open-Label, Multicentre Feasibility Study

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

PT (2); CN (1)