NCT07841574

HAIC Plus QL1706 & Bevacizumab in Unresectable HER2-Negative ICC

StatusRecruiting

PhasePhase 2

SponsorLianghe Lu

Primary completionJun 30, 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Sep 21, 2026 Study First Submitted

Endpoints

Primary

objective response rate，ORR

Timeframe: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.

Secondary (4)

disease control rate, DCR

progression-free survival, PFS

Overall survival, OS

Safety evaluation

Arms and interventions

Hepatic Arterial Infusion Chemotherapy (HAIC) Combine QL1706 and bevacizumabExperimental

Drugs: hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab

Sites

1 site in 1 country

Sun Yat-sen university cancer centerGuangzhou, Guangdong, China

About this trial

Intrahepatic cholangiocarcinoma (ICC) has an increasing global incidence, and over 70% of patients are diagnosed at unresectable stages with limited survival benefits from standard first-line chemotherapy regimens. Hepatic arterial infusion chemotherapy (HAIC) delivers high-concentration local chemotherapy to liver tumors, while the PD-1/CTLA-4 dual antibody iparomlimab and tuvonralimab (QL1706) combined with bevacizumab can reshape the immunosuppressive tumor microenvironment and exert synergistic anti-tumor effects.The purpose of this study is to evaluate the efficacy and safety of HAIC-FOLFOX plus QL1706 and bevacizumab as first-line therapy for patients with unresectable HER2-negative intrahepatic cholangiocarcinoma.

Trial details

Enrollment: 35 participants (estimated)
Started: Jun 11, 2026
Study completion: Jun 30, 2029 (estimated)
Eligibility: 18 to 75, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Conditions: Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Official title: Hepatic Arterial Infusion Chemotherapy Combined With Iparomlimab/Tuvonralimab (QL1706) and Bevacizumab in Patients With Unresectable HER2-Negative Intrahepatic Cholangiocarcinoma:A Prospective Phase II Study
First posted: Sep 25, 2026
Registry updated: Sep 25, 2026
Last verified: Sep 2026

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