Pancreatic Cancer Clinical Trials

Find Pancreatic Cancer Clinical Trials Near You

A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• Histologically and/or cytologically proven locally advanced pancreatic adenocarcinoma

• Target lesion is technically amenable for Alpha DaRT sources implantation.

• Measurable lesion per RECIST (version 1.1) criteria

• Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX

• Lesion size ≤ 5 cm in the longest diameter

• Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure

• Patients have received 8 - 12 cycles of mFOLFIRINOX

• ECOG Performance Status Scale 0 - 1

• Life expectancy is more than 6 months

• WBC ≥ 3500/µl, granulocyte ≥ 1500/µl

• Platelet count ≥60,000/µl

• Creatinine ≤1.9 mg/dL

• AST and ALT ≤ 2.5 X upper limit of normal (ULN)

• INR \< 1.4 for patients not on Warfarin

• Age ≥18 years old

• Subjects are willing and able to sign an informed consent form

• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy

• Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.

Locations
Other Locations
France
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
Centre Jean PERRIN - Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Centre Georges François Leclerc Dijon
NOT_YET_RECRUITING
Dijon
Centre Georges François Leclerc Dijon
NOT_YET_RECRUITING
Dijon
Centre Georges François Leclerc Dijon
NOT_YET_RECRUITING
Dijon
CHU Grenoble Alpes
RECRUITING
Grenoble
Hôpital Privé Mermoz - Lyon
NOT_YET_RECRUITING
Lyon
Marseille
NOT_YET_RECRUITING
Marseille
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
Gustave Roussy Institute
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Liron Dimnik
LironD@alphatau.com
972-54-2688602
Backup
Aviya Hoida
aviyah@alphatau.com
972-54-7869466
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 40
Treatments
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Related Therapeutic Areas
Sponsors
Leads: Alpha Tau Medical LTD.

This content was sourced from clinicaltrials.gov