5. No prior systemic therapy or tumor-related surgery, except biliary drainage.
6. No extrahepatic metastasis.
7. Considered technically resectable by an experienced hepatobiliary surgeon.
8. At least one measurable lesion according to RECIST 1.1.
9. Adequate organ and bone marrow function, as defined by the protocol.
10. Women of childbearing potential must have a negative serum pregnancy test within 7 days before treatment and agree to use effective contraception during the study and for 1 year after the last study treatment. Male participants with partners of childbearing potential must also agree to use effective contraception during the study and for 1 year after the last study treatment.
11. Life expectancy of at least 12 weeks.
You may not be if
Participants meeting any of the following criteria will be excluded:
1. Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components.
2. Prior systemic therapy or other tumor-related treatment, except biliary drainage.
3. Diagnosis of any other malignancy within 5 years before the first study treatment, except cured localized tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, or low-grade prostate cancer.
4. Known uncontrolled pulmonary fibrosis, interstitial lung disease, or acute lung disease.
5. Participation in another clinical trial of an investigational drug or device within 4 weeks before the first study treatment.
6. Active hepatitis B or hepatitis C infection.
7. Active autoimmune disease requiring systemic treatment within 2 years before the first
Clareo Health | Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial