NCT07138885

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Days – 65 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatocellular Carcinoma (HCC)
• Second Line Treatment

Interventions

Type	Name	Description
PROCEDURE	HAI-FOLFOX + bevacizumab + QL1706	Arm 1: HAI-FOLFOX Administration (Day 1 of Each Cycle) Super-selective insertion the arterial catheter into the tumor-feeding artery, then infusion: Oxaliplatin: 85 mg/m², Leucovorin: 400 mg/m², 5-FU: 2500 mg/m² Administer bevacizumab (7.5 mg/kg; total dose capped at 300 mg or 400 mg) via arterial infusion. Then QL1706 (5 mg/kg, IV infusion, Q3W). Treatment Schedule: Repeat HAI-FOLFOX + arterial bevacizumab every 3 weeks (max 6 cycles), followed by QL1706 maintenance (Q3W).
PROCEDURE	TACE + bevacizumab + TAS-102 + QL1706	Arm 2: On-Demand TACE (Lipiodol: ≤10 mL, mixed with platinum + doxorubicin agent, each ≤50 mg) to form an emulsion. Repeat TACE until TACE resistance develops (typically \~4 sessions). Administer bevacizumab (7.5 mg/kg; total dose capped at 300 mg or 400 mg) via intra-arterial route. After first TACE, begin TAS-102 (15 mg/m² po BID) once liver function recovers to acceptable levels. Then QL1706 (5 mg/kg, IV infusion, Q3W).

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-07-31
• Completion: 2028-07-31
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: China