Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

Launched by ALPHA TAU MEDICAL LTD. · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for pancreatic cancer that combines a special type of radiation therapy called Alpha DaRT with chemotherapy. The goal is to see if this combination can safely help improve the outcomes for patients with locally advanced or metastatic pancreatic cancer, which means the cancer has spread from its original site. The study will look at how well this treatment works in managing pain, improving survival rates, and whether it allows doctors to perform surgery on patients in the first group.

To be part of this trial, patients need to be at least 18 years old and have a specific type of pancreatic cancer that has not been treated before, with certain health conditions that allow them to safely receive treatment. Participants will first receive chemotherapy for a few cycles, followed by the Alpha DaRT therapy. Throughout the trial, patients will be monitored closely for any side effects and overall health. This study is not yet recruiting participants, but if you or someone you know has pancreatic cancer and meets the criteria, it could be an opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).
• • Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
• • Target lesion is technically amenable for Alpha DaRT sources implantation.
• • Measurable lesion per RECIST (version 1.1) criteria
• • Lesion size ≤ 5 cm in the longest diameter
• • Interstitial radiation indication validated by a multidisciplinary team.
• • ECOG Performance Status Scale 0 -2
• • 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:
• • For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
• • For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
• • 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 DaRT insertion.
• • 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 DaRT insertion
• • Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.