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Irinotecan

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Eligible patients will undergo neoadjuvant FOLFIRINOX chemotherapy with the following order and dosing schedule:

Irinotecan hydrochloride trihydrate is administered intravenously over approximately 90 minutes at a dose of 180 mg/m\^2.

Oxaliplatin is given intravenously over 2 hours at a dosage of 85 mg/m\^2.

5-Fluorouracil is administered intravenously over approximately 46 hours at a dosage of 2400 mg/m\^2. This treatment regimen is a modified FOLFIRINOX protocol.

Perioperative Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX)

FOLFIRINOX chemotherapy

Jin He, MD, PhD

This is a Phase II, Open-Label, Single Arm trial investigating the outcomes of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma.

This clinical trial aims to evaluate the effectiveness and safety of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma. FOLFIRINOX is administered in 14-day cycles following a specific treatment protocol. The primary goal is to assess treatment effectiveness, with secondary objectives including evaluating safety, impact on patients' health-related quality of life (HR-QoL), and analyzing the tumor microenvironment in organ-specific metastases of pancreatic cancer. An exploratory objective involves analyzing overall survival while considering HR-QoL in patients enrolled in a separate Institutional Review Board protocol for quality of life assessment.

Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

Perioperative Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX) For Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC): A Phase II, Open-Label, Single Arm Trial

To assess the efficacy of neoadjuvant FOLFIRINOX chemotherapy followed by R0/R1 resection in patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas

Determine the rate of complete (R0) and near-complete (R1) tumor resections following neoadjuvant chemotherapy.

Assess the overall survival of patients receiving neoadjuvant chemotherapy for pancreatic cancer.

Analyze the progression-free survival (PFS) in patients who achieve R0/R1 resection status, as per the RECIST v1.1 criteria, following neoadjuvant chemotherapy.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Topoisomerase I Inhibitors

Enzyme Inhibitors

Subjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy

Subjects in Arm B will be implanted with the OncoSil™ device in addition to up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy

Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer

Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance

OncoSil™

Henk Tissing

Tom Maher

Nam Nguyen, MD

Daniel Croagh, MD

Els Monsaert, MD

Carlo Garufi, MD

Guido Ventroni, MD

Michele Milella, MD

Giuseppe Malleo, MD

Teresa Macarulla, MD

Andrés Muñoz, MD

Rocio Garcia-Carbonero, MD

Ignacio Juez, MD

Carmen Guillen Ponce, MD

Mariano Ponz Sarvisé, MD

Paul Ross, MD

Harpreet Wasan, MD

Richard Hubner, MD

Joe Geraghty, MD

Sanjay Pandanaboyana, MD

Ben Maher, MD

Michele Milella, MD, PhD

Giuseppe Malleo, MD, PhD

The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer

Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will be informed about the study and the potential risks and benefits. After providing informed consent patients will undergo a 3 week screening period to confirm eligibility for the study. Patients who meet all eligibility criteria will be randomised 1:1 to either the control arm of up to 12 cycles of standard of care FOLFIRINOX chemotherapy or implantation of OncoSil™ in addition to the same FOLFIRINOX chemotherapy regimen. Patients will be followed for side side effects and palliative benefits during 4-8 weekly study visits and the objective efficacy of the treatment will be assessed by CT scans every 8 weeks. Quality of Life will be measured on various time-points using questionnaires.

FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma

An Open-label, Multi-centre, Randomized Study of TaRgeted Intratumoural Placement of P-32 (OncoSil™) in Addition to FOLFIRINOX Chemotherapy vs FOLFIRINOX Alone in Patients With Unresectable Locally Advanced Pancreatic Adenocarcinoma.

IPD may be shared on an individual basis to study investigators subject to review and approval from the study publication steering committee

The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile

The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks

Local Progression Free Survival (LPFS) is defined as the time from enrolment to the date of the radiological scan used to determine local tumour progression or date of death from any cause, whichever comes first.

Progression free survival (PFS) is defined as the time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR) or resection of the primary pancreatic tumour), or death from any cause, whichever comes first.

Time to symptomatic progression is defined as the time between enrolment and worsening of cancer related symptoms as measured by the symptoms domains of QLQ-C30/PAN26

Clinical Benefit Response is a composite endpoint consisting of weight, Performance Status and pain score and will be derived at 4 weekly intervals.The frequency and percentage of subjects with a clinical benefit response will be summarised

CA 19-19 response will be defined as ≥ 50% decline from baseline and ≥ 90% decline from baseline and return to normal range respectively. Subgroups will be created for study subjects with CA 19-9 \> ULN at baseline.

Overall survival (OS) is the time from enrolment to the date of death from any cause.

EQ-5D, EORTC QLQ-C30 and PAN26 will be analyses per their validated methodology

weight will be assessed at all applicable study visits

assessment of rate of secondary R0/R1 resection

A central reading centre will analyse all CT scans to measure target tumour volume changes from baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma	NCT06122480	Pancreatic Duct... Oligometastatic...	FOLFIRINOX chem...	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma	NCT05466799	Locally Advance...	FOLFIRINOX chem... OncoSil™	18 Years -	OncoSil Medical Limited
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma	NCT06122480	Pancreatic Duct... Oligometastatic...	FOLFIRINOX chem...	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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