A Phase II, Single-Arm, Prospective Trial on the Efficacy and Safety of QL1706 Combination Regime… (NCT07138885) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
China62 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range18 Days – 65 Days
SexALL
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Inclusion criteria
✓. Voluntary Participation, Willingly signs the written informed consent form.
✓. Aged 18-65 years (inclusive), any gender.
✓. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) with disease progression after first-line targeted therapy combined with immunotherapy, or intolerable to first-line targeted-immunotherapy combination treatment.
✓. No prior exposure to VEGF monoclonal antibodies, CTLA-4 inhibitors, or bispecific antibodies. For arm 1: No prior treatment with oxaliplatin or fluorouracil-based drugs.
✓. Liver Function: Child-Pugh class A or class B (score ≤7), with no history of hepatic encephalopathy.
✓. Performance Status: ECOG PS score 0 or 1.
✓. Life Expectancy ≥12 weeks.
✓. Measurable Lesion: ≥1 measurable target lesion per RECIST v1.1 (not previously irradiated/localized; lesions in prior treatment areas are acceptable if progression is confirmed).
Exclusion criteria
What they're measuring
1
Objective response rate (ORR) by RECIST 1.1
Timeframe: From date of first dose of study drug until disease progression (up to approximately 3 years)
✕. Other active malignancies within 5 years prior to enrollment, except cured localized tumors (e.g., basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, in situ prostate/cervical/breast cancer).