For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.
This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.
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
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
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor