A Phase II, Single-Arm, Prospective Trial on the Efficacy and Safety of QL1706 Combination Regimen as Second-Line Therapy for Targeted-Immunotherapy-Resistant Hepatocellular Carcinoma

The goal of this prospective Phase II clinical trial is to evaluate the efficacy and safety of QL1706-based combination therapy in patients with hepatocellular carcinoma (HCC) who have failed prior targeted-immunotherapy (e.g., anti-PD-1/PD-L1 + antiangiogenic therapy). The main question is: Can the combination of localized-regional therapy (e.g., HAIC/TACE) and systemic dual immunotherapy (QL1706) overcome resistance and improve outcomes in second-line HCC treatment? Participants will: 1. Receive QL1706 (a dual immune checkpoint inhibitor) combined with either: Hepatic arterial infusion chemotherapy (HAIC)/transarterial chemoembolization (TACE), or Antiangiogenic targeted therapy. 2. Undergo regular imaging (e.g., MRI/CT) and biomarker assessments for efficacy monitoring. 3. Be evaluated for adverse events (AEs) and quality of life. This study seeks to establish a novel therapeutic paradigm for HCC patients after targeted-immunotherapy failure, addressing the unmet need for evidence-based second-line strategies.

NCT Number	NCT07138885
Lead Sponsor	Sun Yat-sen University Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions	Hepatocellular Carcinoma (HCC), Second Line Treatment
Enrollment	62 participants
Start Date	2025-08-01
Primary Completion	2027-07-31 (estimated)
Study Completion	2028-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-29