Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer

Launched by ALPHA TAU MEDICAL LTD. · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients with locally advanced pancreatic cancer, which is a type of cancer that cannot be removed by surgery. The treatment involves using a special device that delivers alpha radiation directly into the tumor. This method aims to target the cancer cells more precisely while minimizing damage to surrounding healthy tissue. The trial is not yet recruiting participants, but it is designed for adults aged 18 and older who have already undergone at least one round of chemotherapy or are unable to have further chemotherapy.

To be eligible for this trial, patients must have a confirmed diagnosis of advanced pancreatic cancer, and their tumor must meet specific size requirements. They should also have a life expectancy of more than six months and be in reasonably good health. Participants will need to sign an informed consent form, agreeing to use contraception during the study and for three months afterward if they are of childbearing potential. Throughout the trial, patients can expect close monitoring of their health and the effects of the treatment. This research is an important step in finding new options for people facing this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically and/or cytologically proven NCCN locally advanced PC
• • Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.
• • DaRT indication validated by a multidisciplinary team.
• • Measurable lesion per RECIST (version 1.1) criteria
• • TC at Verona's center (not been over a month)
• • Lesion size ≤ 5 cm in the longest diameter
• • Age ≥18 years old
• • ECOG Performance Status Scale ≤ 2
• • Life expectancy is more than 6 months
• • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
• • Platelet count ≥60,000/μl
• • Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
• • AST and ALT ≤ 2.5 X upper limit of normal (ULN)
• • INR \< 1.4 for patients not on Warfarin
• • 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 brachytherapy.
• • 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 discontinuing therapy.
• Exclusion Criteria:
• • Concomitant chemotherapy or immunotherapy within the past 4 weeks
• • Prior radiation therapy to the pancreas
• • CA 19-9 \> 1000 Units/ml
• • Fit for surgical exploration unless the 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 (not including cholangitis) 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 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.