None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to investigate whether adding a targeted internal radiation treatment called OncoSil™ to standard chemotherapy, with or without immunotherapy, can improve outcomes for people with metastatic pancreatic cancer. Who is it for? You may be eligible for this study if you are male or female aged 18 or older, have confirmed pancreatic ductal adenocarcinoma that has spread to a limited number of sites (oligo-metastatic disease), who are well enough to receive standard chemotherapy and meet the study's health and laboratory requirements. Study details All those who are eligible will be randomly allocated to one of three treatment groups: (1) OncoSil™ plus chemotherapy, (2) OncoSil™ plus chemotherapy and immunotherapy (nivolumab), or (3) chemotherapy standard care. Participants receiving OncoSil™ will undergo a single endoscopic ultrasound (EUS)-guided implantation of phosphorus-32 microparticles into the primary pancreatic tumour approximately four weeks after starting chemotherapy. All participants will attend regular follow-up visits, which include clinical reviews, imaging scans, blood sample collection, and completion of quality of life and pain questionnaires. Researchers will also analyse blood and, where available, tumour samples to better understand how OncoSil™ affects the immune system and response to treatment. The findings may help determine whether this treatment approach could improve future care for people with metastatic pancreatic cancer.
Interventions
Arm 1 – OncoSil™ plus chemotherapy
Participants will receive standard-of-care chemotherapy together with a single implantation of OncoSil™ (phosphorus-32 microparticles) into the primary pancreatic tumour. The OncoSil™ implant will be performed approximately 4 weeks after commencing chemotherapy using endoscopic ultrasound (EUS)-guided implantation by experienced gastroenterologists/endosonographers trained in the OncoSil™ procedure at the Royal Adelaide Hospital. Chemotherapy will continue acco
Arm 1 – OncoSil™ plus chemotherapy Participants will receive standard-of-care chemotherapy together with a single implantation of OncoSil™ (phosphorus-32 microparticles) into the primary pancreatic tumour. The OncoSil™ implant will be performed approximately 4 weeks after commencing chemotherapy using endoscopic ultrasound (EUS)-guided implantation by experienced gastroenterologists/endosonographers trained in the OncoSil™ procedure at the Royal Adelaide Hospital. Chemotherapy will continue according to standard clinical practice. Participants will attend scheduled follow-up visits for clinical review, imaging, blood sample collection, and completion of study questionnaires. Adherence to study assessments will be monitored by the study team, with appointment reminders provided where required. Arm 2 – OncoSil™ plus chemotherapy and immunotherapy Participants will receive standard-of-care chemotherapy together with a single EUS-guided OncoSil™ implantation as described for Arm 1. Participants will also receive immunotherapy (nivolumab) administered according to the treating oncologist's prescribed schedule and institutional clinical practice. Immunotherapy will be delivered in the oncology outpatient setting by appropriately qualified oncology staff. Participants will undergo the same study assessments and follow-up schedule as Arm 1. Study visit adherence will be monitored by the research team. For participants allocated to Arm 1 or Arm 2, the dose of OncoSil will be calculated prior to the procedure to achieve an Implanted Volume/Tumour Volume of 8% to deliver a dose of 100Gy to the tumour mass. Standard of care diagnostic imaging pre-chemotherapy will be accessed to assist with dose calculations, and on the day of the procedure the dose can be adjusted if the endoscopist determines if the tumour volume has increased/decreased since prior tumour volume assessment. For participants allocated to Arm 2, the dose of nivolumab will be approximately 240mg, and provided every 2 weeks for about 6 months. Intervention fidelity will be assessed through review of medical records, procedural reports, and treatment records. OncoSil implantation details will be documented by the treating endoscopist/investigator. Post-implantation Bremsstrahlung SPECT/CT imaging will be performed same day to confirm localisation of implanted OncoSil. The participants adherence to chemotherapy and immunotherapy schedules will be assessed through review of hospital administration records.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Histologically or cytologically proven adenocarcinoma of the pancreas. -Pancreatic ductal adenocarcinoma with oligo-metastasis (< 5 lesions in liver, < 3 lesions in lung) -Pancreatic target tumour diameter of less than/equal to 6.0 cm (longest axis) -An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 – 100. -Standard chemotherapy will be commenced within 14 days post enrolment. -Willing and able to complete study procedures within the study timelines. -Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN). -Adequate liver function: Serum SGOT/AST and serum SGPT/SLT < 3 times ULN and serum bilirubin <1.5 times the ULN unless the patient is known to have prior Gilbert’s Syndrome. -Adequate bone marrow function: white blood cells (WBCs) greater than/equal to 3,000/mm3, absolute neutrophil count (ANC) greater than/equal to 1,500/mm3, haemoglobin greater than/equal to 9 g/dL, and platelets greater than/equal to 100,000/mm3. -Life expectancy of at least 3 months at the time of screening as judged by the investigator. -Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device. -Provide signed Informed Consent.
Exclusion criteria
-More than one primary lesion. -Any prior radiotherapy or chemotherapy for pancreatic cancer. -Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit, whichever is longer. -Pregnant or lactating. -History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ. -Evidence of more than 2 metastatic sites or peritoneal metastasis with ascites. -Patients who do not consent to chemotherapy -Any other health condition that would preclude participation in the study in the judgment of the investigator.
Outcome results
None listed