This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma.
Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.
Age ≥18 years.
Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis.
No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma.
At least one measurable intrahepatic lesion according to RECIST v1.1.
Diffuse infiltrative liver lesions.
Contraindications to TACE.
Allergy to intravenous contrast agent.
pregnant or breastfeeding women, or participants planning pregnancy within 2 years / unwilling to use effective contraception.
Parallel
Gemcitabine
DrugGemcitabine 1000 mg/m² intravenously on Days 1 and 8 of each 21-day cycle, up to 8 cycles.
Cisplatin
DrugCisplatin 25 mg/m² intravenously on Day 1 and Day 8 of each 21-day cycle, up to 8 cycles.
Tislelizumab
DrugTislelizumab 200 mg intravenously on Day 1 of each 21-day cycle, followed by maintenance tislelizumab every 3 weeks.
Lenvatinib
DrugOral lenvatinib once daily, 12 mg for participants with body weight ≥60 kg or 8 mg for participants with body weight \<60 kg, with dose modification according to toxicity.
Transcatheter Arterial Chemoembolization
Procedure/SurgeryConventional TACE or drug-eluting bead TACE are allowed. TACE may be repeated based on imaging assessment every 6 weeks ±7 days and investigator judgment.
Hepatic Arterial Infusion Chemotherapy
Procedure/SurgeryOptional hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to protocol-defined dose ranges.
Overall Survival
Overall survival is defined as the time from enrollment/randomization to death from any cause. Participants who withdraw are lost to follow-up or remain alive at the end of the study will be censored at the date they were last known to be alive.
Progression-Free Survival
Defined as the time from randomization to disease progression or death from any cause. Participants without progression or death will be censored at the last date known to be progression-free.
Time to Progression
Defined as the time from randomization to disease progression. Participants who die without prior progression, withdraw, are lost to follow-up, or remain progression-free at study end will be censored at the last date known to be progression-free.
Objective Response Rate
Defined as the proportion of participants achieving complete response or partial response according to RECIST v1.1.
Disease Control Rate
Defined as the proportion of participants achieving complete response, partial response, or stable disease according to RECIST v1.1.
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