Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

This is a phase III, multicenter, open‐label, randomized controlled trial designed toevaluate the efficacy and safety of arterially directed therapy in combination withtislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) incombination with tislelizumab as first‐line treatment for patients with unresectableintrahepatic cholangiocarcinoma.Approximately 140 eligible patients with histologically confirmed unresectableintrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled andrandomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib orGEMCIS plus tislelizumab. In the TACE‐based treatment arm, hepatic arterial infusionchemotherapy with gemcitabine and cisplatin may be administered during or after TACE atthe investigator's discretion according to the protocol.The primary endpoint is overall survival. Secondary endpoints include progression‐freesurvival, time to progression, objective response rate, disease control rate, safety, andquality of life.