Intrahepatic Cholangiocarcinoma (ICC)
Conditions
Interventions
Case series:NA
Sponsors
Shanghai Tenth People's Hospital Ethics Committee
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, gender unlimited; 2. Histopathologically confirmed intrahepatic cholangiocarcinoma (ICC); 3. Unresectable and naive to prior systemic anti-tumor therapy; 4. Planned to receive standard first-line immune checkpoint inhibitor (PD-1/PD-L1 mAb) combined with chemotherapy (e.g., Gemcitabine + Cisplatin/Oxaliplatin); 5. Availability of pre-treatment formalin-fixed paraffin-embedded (FFPE) biopsy tissue samples for pathological analysis; 6. Presence of at least one measurable lesion evaluable by imaging according to RECIST 1.1 criteria; 7. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of other malignancies; 2. Prior immunotherapy or local therapy for ICC (e.g., TACE, ablation); 3. Active autoimmune disease requiring chronic use of corticosteroids or immunosuppressants; 4. Insufficient biopsy tissue for H&E staining and digital scanning; 5. Estimated life expectancy < 3 months; 6. Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);ROC curve;AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactJun Li
Department of Hepatobiliary and Pancreatic Surgery, Tenth People’s Hospital of Tongji University
Outcome results
None listed