Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Experimental Group:HAIC+PD-1
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years, inclusive; both genders eligible. 2.Histologically confirmed intrahepatic cholangiocarcinoma with at least one measurable lesion per RECIST v1.1 criteria. 3.ECOG Performance Status of 0 to 2. 4.Child-Pugh class A or B; anticipated life expectancy exceeding 3 months. 5.Deemed ineligible for curative surgical resection based on clinical evaluation. 6.No prior exposure to systemic chemotherapy or immune checkpoint inhibitors. 7.Adequate organ function without concurrent failure of other vital organs. 8.Voluntary participation with written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1.History of other malignant tumors within the past 5 years. 2.Presence of active, known or suspected autoimmune diseases. (Exceptions: Patients with hypothyroidism requiring hormone replacement therapy only, or those with skin disorders not requiring systemic treatment may be enrolled.) 3.Known allergy to the investigational drug(s). 4.Severe active infection requiring intravenous antibiotic treatment during the screening period. 5.Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or severely impaired pulmonary function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactYan Liu
Harbin Medical University Cancer Hospital
Outcome results
None listed