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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 (DRIVE-II)

NCT07138885 PHASE2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsorSun Yat-sen University
PhasePHASE2
StatusACTIVE_NOT_RECRUITING
Enrolment62
Start dateFri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionMon Jul 31 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

China