NCT07304388

HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC

Systemic Chemotherapy, Lenvatinib and Toripalimab With or Without Hepatic Arterial Infusion In Advanced Intrahepatic Cholangiocarcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC. Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
PROCEDURE	hepatic arterial infusion chemotherapy (HAIC)	Hepatic arterial infusion chemotherapy: oxaliplatin 85mg/m2 via HAIC pump for 3 hours on day 1; Q3W Drug: Gemcitabine 1g/m2 intravenously on day 1 and day 8 of a 3 weeks cycle Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W
DRUG	Chemotherapy	Systemic chemotherapy of GemOx regimen: oxaliplatin 85mg/m2 and gemcitabine 1g/m2 intravenously on day 1, and gemcitabine 1g/m2 intravenously on day 8 of a 3 weeks cycle. Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W

Timeline

• Start date: 2023-02-10
• Primary completion: 2025-04-01
• Completion: 2025-06-01
• First posted: 2025-12-26
• Last updated: 2025-12-30

Locations

1 site across 1 country: China