Local advanced/Metastatic intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Combined Cryoablation with Lucatumumab and Immune Checkpoint Inhibitors Therapy
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 80 years; 2.Cytologically or histopathologically confirmed, locally advanced or metastatic intrahepatic cholangiocarcinoma; 3.Disease progression after receiving at least one prior line of systemic therapy; 4.Presence of at least one measurable primary lesion according to RECIST 1.1 criteria; 5.No active autoimmune diseases; 6.No concurrent malignancy; 7.ECOG performance status of 0 or 1; 8.Life expectancy >= 3 months; 9.Adequate organ and marrow function (without blood transfusion, thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: (1) Hematology: Absolute neutrophil count (ANC) >= 1.2×10^9/L; Platelet count (PLT) >= 90×10^9/L; Hemoglobin >= 9 g/dL; (2). Hepatic Function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline phosphatase (ALP) <= 2.5 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) <= 1.5 × ULN. For patients with liver metastases, ALT and AST must be <= 5 × ULN. 10.For subjects of childbearing potential and male subjects with partners of childbearing potential, agreement to use effective methods of contraception from the time of signing the informed consent form until 6 months after the last dose; 11.Subjects voluntarily agree to participate in the study by providing written informed consent and are able to comply with scheduled visits and related procedures as specified in the protocol;
Exclusion criteria
Exclusion criteria: 1.Prior treatment targeting TROP2; or any therapy containing a topoisomerase I inhibitor, including antibody-drug conjugate (ADC) therapy; 2.History of other malignancies within the past 3 years prior to dosing (except for tumors cured with local therapy, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.); 3.Known hypersensitivity to any component of the investigational drug (Lucan-Sartuzumab); 4.History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; 5.Presence of local or systemic diseases not caused by the malignancy, or tumor-related conditions/symptoms that would lead to increased medical risks and/or uncertainty in survival evaluation, such as leukemoid reaction or manifestations of cachexia; 6.Documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or a history of corneal disease that prevents or delays corneal healing; 7.Known active tuberculosis. Subjects suspected of having active tuberculosis must be ruled out through clinical evaluation. 8.Women who are pregnant or breastfeeding; 9.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to response;Disease Control Rate (DCR);Progression-Free Survival (PFS);Overall Survival;Duration of Response (DOR);Adverse Events; | — |
Countries
China
Contacts
Public ContactJiansong Ji
Lishui Central Hospital
Outcome results
None listed