Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

Inclusion criteria

• Age 18 or above
• Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
• A tumor that cannot be removed by three independent surgeons.
• Expected lifespan ≥ 12 weeks
• ECOG PS score 0-1 points
• The patient voluntarily participates and signs an informed consent form;
• Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.

Exclusion criteria

• Use any systemic research anti-cancer drugs
• Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
• Asthma requires the use of bronchodilators for medical intervention
• Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
• Clinical symptoms or uncontrolled heart disease
• Severe infection within 4 weeks before the first use of medication
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Vaccination with attenuated live vaccine within 4 weeks before treatment
• Other systemic malignant tumors in the past 5 years