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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 26, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07691515). This is a study registration, not published results. Lead sponsor: Zhejiang Cancer Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 140 participants (ESTIMATED). Conditions: Intrahepatic Cholangiocarcinoma (Icc). Interventions: DRUG: Gemcitabine; DRUG: Cisplatin; DRUG: Tislelizumab; DRUG: Lenvatinib; PROCEDURE: Transcatheter Arterial Chemoembolization; PROCEDURE: Hepatic Arterial Infusion Chemotherapy. Primary outcome measures: Overall Survival , From randomization to death from any cause, assessed up to approximately 48 months. Brief summary: 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.