Actively Recruiting
Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma
Led by National Cancer Institute, Naples · Updated on 2024-11-07
38
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.
CONDITIONS
Official Title
Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving signed informed consent and complying with study requirements
- Histologically or pathologically confirmed cholangiocarcinoma
- Age over 18 years at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Locally advanced disease confirmed by multidisciplinary assessment
- Life expectancy of at least 16 weeks
- Body weight greater than 30 kg
- Adequate organ and marrow function: Hemoglobin 9.0 g/dL, ANC 1.5 �d7 10^9/L, Platelets 100 �d7 10^9/L
- Serum bilirubin 1.5 times institutional upper limit of normal (except for confirmed Gilbert's syndrome with physician approval)
- AST/ALT 2.5 times ULN (up to 5 times if liver metastases present)
- Creatinine clearance greater than 40 mL/min by measurement or calculation
- At least one RECIST 1.1 target lesion on CT or MRI within 28 days before randomization
- No prior systemic or local cancer treatments including radiation, radiofrequency ablation, or electro-chemotherapy
You will not qualify if you...
- Previous participation in another interventional clinical study
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders except specific controlled conditions
- Uncontrolled illnesses or infections that could affect compliance or safety
- Recent bowel obstruction, refractory ascites, or bowel perforation within 3 months before treatment
- Significant bleeding disorders or serious wounds
- History of other primary cancers except certain treated malignancies without active disease
- History of leptomeningeal carcinomatosis
- Brain metastases or spinal cord compression
- Active primary immunodeficiency
- Known active hepatitis B or C infection; specific resolved infections allowed
- Known HIV infection or active tuberculosis
- Recent use of immunosuppressive medications before study drugs except certain steroid uses
- Receipt of live attenuated vaccine within 30 days before first study drug dose
- Pregnancy, breastfeeding, or unwillingness to use effective birth control
- Known allergy or hypersensitivity to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, Italia, Italy, 80131
Actively Recruiting
2
Ospedale Cardarelli, Napoli
Naples, Italia, Italy, 80131
Not Yet Recruiting
3
Università di Napoli "Federico II", Napoli
Naples, Italia, Italy, 80131
Not Yet Recruiting
4
Ospedale san Camillo Forlanini/Spallanzani, Roma
Roma, Italia, Italy, 00152
Not Yet Recruiting
5
Ospedale Mauriziano, Umberto I°
Torino, Italia, Italy, 10128
Not Yet Recruiting
6
Università di Verona, Ospedale Borgoroma, Verona
Verona, Italia, Italy, 37134
Not Yet Recruiting
Research Team
A
Alessandro Ottaiano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here