Actively Recruiting
Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
Led by Impact Biotech Ltd · Updated on 2026-02-12
30
Participants Needed
2
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the target artery(superior mesenteric artery (SMA), celiac artery (CA) or common hepatic artery (CHA)). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.
CONDITIONS
Official Title
Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age and older
- Capable of giving written informed consent
- Diagnosis of Stage III pancreatic ductal adenocarcinoma confirmed by cytology or histology
- Unresectable tumor evaluated as Stage III by NCCN guidelines based on imaging or surgery
- Tumor located in the head or uncinate process of the pancreas
- Target artery solid tumor contact ≥180° for up to 3cm length with artery internal diameter 5-10 mm
- Approval by multidisciplinary team including oncologist, surgeon, and interventional radiologist
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status ≤1
- Life expectancy of at least 6 months
- No evidence of metastatic disease on CT chest, abdomen, and pelvis within 28 days before treatment
- Adequate organ function including specified blood counts, coagulation, kidney function, and liver enzymes
- May have received prior neoadjuvant chemotherapy and/or immunotherapy
- No prior external beam radiation therapy to the pancreas
- Prior attempted surgical resection is allowed
- No comorbidities preventing access to the target artery by catheterization
- Male or nonpregnant, nonlactating female aged 18 years or older
- Women of child-bearing potential must test negative for pregnancy at screening
- Female subjects of reproductive potential must agree to use two effective birth control methods during and for 1 month after study
- Male subjects must agree to use condoms during and for 90 days after the study
You will not qualify if you...
- Metastatic (stage IV) disease
- Superior mesenteric artery (SMA) not originating from aorta
- Any vascular abnormality preventing safe balloon and device placement in target artery
- Moderate to severe atherosclerotic flow limiting changes in target vessel
- Significant stenosis of the celiac artery
- Previous radiotherapy for pancreatic cancer
- Tumor cystic component ≥25% of total tumor volume
- Moderate to severe ascites not controlled by medication
- Known additional malignancy requiring active treatment
- History of congestive heart failure or recent myocardial infarction within 6 months
- Unable to tolerate moderate or deep sedation
- Medical or social conditions interfering with consent, cooperation, or study participation
- Unwilling or unable to comply with study procedures and visits
- Prior definitive surgical resection for pancreatic cancer
- Pregnant or nursing
- Active infection
- Known allergy to iodine contrast
- Receipt of concurrent investigational therapy or within 30 days before study
- Significant medical or psychiatric comorbidities making patient unsuitable
- Systemic chemotherapy within 14 days before planned treatment (preferred 30 days washout)
- VEGF-targeted therapy within 2 months before planned treatment
- Use of prohibited medications that cannot be adjusted before study
- Photosensitive skin diseases or porphyria
AI-Screening
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Trial Site Locations
Total: 2 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
Research Team
E
Eyal Morag, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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