Clinical trial NCT06755359: Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer
Official title: A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Locally Advanced Pancreatic Cancer
Keywords: Alpha radiation
pancreatic cancer
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 .

Detailed description: This study will be a prospective, interventional, open label, single arm, multiple center study.

Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Concomitant immunotherapy within the past 4 weeks.
* Patients with metastatic disease
* Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery.
* Known hypersensitivity to any of the components of the treatment.
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.
* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
* Patients do not 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 discontinuing therapy.
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* High probability of protocol non-compliance (in opinion of investigator).
* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.

Primary outcomes:
measure: Safety - Serious adverse events
timeFrame: from Day 0 , up to 12 months
Secondary outcomes:
measure: Efficacy - tumor response
timeFrame: Day 0 , up to 12 months
measure: Efficacy - overall survival
timeFrame: Day 0 , up to 12 months
measure: Efficacy - Progression-free survival
timeFrame: Day 0 , up to 12 months
measure: Efficacy - Percentage of R0/R1 resected patients
timeFrame: Day 0 , up to 12 months
measure: Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment
timeFrame: Day 0 , up to 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN - Clermont-Ferrand
city: Dijon
country: France
facility: Centre Georges François Leclerc Dijon
city: Dijon
country: France
facility: Centre Georges François Leclerc Dijon
city: Dijon
country: France
facility: Centre Georges François Leclerc Dijon
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Hôpital Privé Mermoz - Lyon
city: Marseille
country: France
facility: Marseille
city: Poitiers
country: France
facility: CHU Poitiers
city: Poitiers
country: France
facility: CHU Poitiers
city: Villejuif
country: France
facility: Gustave Roussy Institute
Study officials:
References: