Precision Medicine in patients with unresectable Cholangiocarcinoma; RadioEmbolization and combined biological therapy

Phase 1

• Conditions: nresectable intrahepatic cholangiocarcinoma; MedDRA version: 20.0Level: LLTClassification code 10073077Term: Intrahepatic cholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-003787-24-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-31
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

- Suspected or biopsy-confirmed diagnosis of intrahepatic cholangiocarcinoma (ICC), not previously treated with systemic or surgical therapies;
- Preserved liver function, defined as: Child Pugh Class A; MELD score (Model forEnd Stage Liver Disease Score} <10;
- No technical contraindication to TARE, confirmed by pre-procedural angiography and scintigraphy;
- Hepatitis B virus (HBV} DNA test and Hepatitis C virus (HCV} RNA test negative at screening;
- Adequate heart and lung function;
- ECOG Performance Score O or 1;
- Adequate renal and hepatic function, as indicated by: serum creatinine <2x the upper limit of normal and estimated glomerular filtration rate (eGFR) >30ml/min or 1.73m/2; alkaline phosphatase (ALP}, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST} s 5 times the upper limit of normal (ULN) and total bilirubin s 2.0 mg/dl;
- Hemoglobin greater than or equal to10 g/dL, platelet count greater than or equal to 70,000/mm3, absolute neutrophil count >1500/mm3.
- Ability and willingness to provide written informed consent and to comply with study protocol and procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

• Pregnant or breastfeeding women;
- Uncorrectable coagulopathies
- Extensive disease extrahepatic or extrarenal
- Tumor classified as combined or mixed type (HCC and ICC} at screening
- Child-Pugh Class B or higher or evidence of severe portal hypertension at screening or at any time up to and including baseline;
- History of major gastrointestinal bleeding requiring medical attention within 30 days prior to screening or at baseline;
- Known hypersensitivity to the specific chemotherapy agents used during the study;
- Any oral or parenteral chemotherapy or immunotherapy treatment within 2 years prior to screening;
- Previous allogeneic bone marrow transplant, kidney or legacy transplant;
- Active viral, bacterial or fungal infections, clinically relevant to the assessment of fitness;
- Current history or evidence of neuropsychiatric illness, including depression, schizophrenia, bipolar disorder, impaired cognition, dementia, or suicidal tendencies;
- History of serious cardiovascular disease, such as a previous stroke, coronary artery disease requiring surgery, or unresolved arrhythmias within the last 6 months.
- Evidence of any hematologic malignancy;
- Positive to human immunodeficiency virus type 1 or 2 (HIV-1, HIV-2) (serum or RNA} and/or hepatitis B virus surface antigen (HBsAg} and/or active infection with Treponema Pallidum or Mycoplasma;
- Abuse of alcohol in the 2 months prior to the study or abuse of any substance in the 6 months prior to the study;
- Known bleeding diathesis or history of abnormal bleeding or any other known coagulation abnormality that may contraindicate future surgery or biopsies;
- Use of immunosuppressant steroids (prednisone equivalent > 10 mg/day};
- Presence of hepatopulmonary shunt >20% or other contraindications to arterial radioembolization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified