Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor

Trial ID: NCT06211933

Interventional - Phase 1/2 - Suspended

This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours : * A Phase I evaluating the tolerance of intraoperative High Intensity Focused Ultrasound (HIFU) intervention on the pancreatic lesion. * A non-randomized Phase II evaluating the preliminary efficacy of the HIFU intervention on the pancreatic lesion. Patients included in Phase I will be monitored and included in the Phase II evaluation.

Conditions

• Non-Resectable Pancreas Carcinoma

Interventions

• HIFU intervention

Eligibility

Inclusion criteria

• Age ≥ 18 years at the day of consenting to the study
• Patient with histologically confirmed locally advanced (unresectable) pancreatic adenocarcinoma according to the National Comprehensive Cancer Network (NCCN) 2020 classification
• Unifocal pancreatic lesion with a maximum diameter of 4 cm
• Non-progressive disease after 4 months of first-line chemotherapy or after 2 months of chemotherapy in case of limiting toxicity contraindicating continuation of chemotherapy;
• Preoperative imaging including CT-scan, MRI of the liver and Positron Emission Computed Tomography scan (PET-CT scan) (except for absolute medical contraindications), within 4 weeks prior to HIFU treatment
• Eastern Cooperative Oncology Group performance status ≤ 2
• Adequate hematologic parameters defined by platelets ≥ 100 Giga/l and hemoglobin ≥ 8 g/dl
• Ability to understand and willingness for follow-up visits
• Patient affiliated to a health insurance scheme (or beneficiary of such a scheme)
• Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment

Exclusion criteria

• Local recurrence of previously operated pancreatic cancer
• Metastatic pancreatic carcinoma
• History of major pancreatic resection
• Chemotherapy completed less than 2 weeks ago
• History of radiotherapy to the pancreas
• Pregnant women
• Possibility of R0 resection with venous reconstruction
• Inability to undergo study follow-up for geographical, social or psychological reasons
• Patient requiring tutorship or curatorship or patient deprived of liberty
• Patient under psychiatric care against his wishes

Sponsor

Centre Leon Berard

Source: ClinicalTrials.gov

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