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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

NCT07138885 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-29

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Pei-Hong Wu, Professor · Sun Yat-Sen University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Days
Max Age
65 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138885 on ClinicalTrials.gov