Actively Recruiting
Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy
Led by Francesco De Cobelli · Updated on 2024-05-24
33
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
F
Francesco De Cobelli
Lead Sponsor
C
Cardarelli Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments.
CONDITIONS
Official Title
Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Liver-predominant intrahepatic cholangiocarcinoma with intermediate or high risk of early recurrence
- Age greater than 18 and up to 80 years at study entry
- Body weight over 30 kg
- Suspicion or biopsy-confirmed intrahepatic cholangiocarcinoma not previously treated with systemic or surgical therapies
- Preserved liver function: Child Pugh Class A; MELD score less than 10; Future Liver Remnant uptake function at least 2.7%/min/m2 and adequate liver volume
- No technical contraindications to radioembolization confirmed by angiography and scintigraphy
- Negative DNA test for hepatitis B virus and RNA test for hepatitis C virus at screening
- Adequate heart and lung function
- ECOG Performance Score of 0 or 1
- Adequate kidney and liver function: serum creatinine less than twice upper limit of normal, eGFR at least 30 ml/min/1.73m2, creatinine clearance above 40 mL/min, liver enzymes and bilirubin within specified limits
- Hemoglobin at least 9 g/dL, platelet count at least 75,000/mm3, absolute neutrophil count at least 1.0 x 10^9/L
- Willing and able to comply with study protocol including treatment and scheduled visits
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Combined or mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma
- Child Pugh class B or higher or severe portal hypertension
- Recent major gastrointestinal bleeding within 30 days before screening
- Known hypersensitivity to chemotherapy agents used
- Allergy or hypersensitivity to study drugs or excipients
- History of allogeneic organ transplant
- Active significant infection
- Current or past neuropsychiatric disease including depression, schizophrenia, bipolar disorder, cognitive impairment, dementia, or suicidal tendencies
- Active or prior autoimmune or inflammatory disorders except specific stable conditions
- Severe cardiovascular disease such as recent stroke or unresolved arrhythmias
- QTcF interval of 470 ms or more on ECG
- Uncontrolled intercurrent illness that may increase risk or limit compliance
- History of another primary cancer except certain treated low-risk malignancies
- History of leptomeningeal carcinomatosis or hematological malignancies
- HIV positive or active hepatitis infection
- Alcohol or substance abuse within specified recent periods
- Pregnant or breastfeeding women or planning pregnancy
- Known bleeding disorders contraindicating surgery or biopsy
- Use of systemic immunosuppressants or steroids above specified doses
- Recent major surgery within 28 days prior to first dose
- Recent live attenuated vaccine within 30 days prior to first dose
- Hepatopulmonary shunt over 20% at diagnostic angiography
- Prior participation in durvalumab clinical trials
- Concurrent enrollment in other interventional clinical studies except observational or follow-up periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiology, IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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