QL1706 in Combination With Bevacizumab and RALOX HAIC for Hepatocellular Carcinoma With Vp3/4 PVTT

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07327788
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bevacizumab
  • Hepatecellular Carcinoma
  • Iparomlimab and Tuvonralimab Injection
  • QL1706
  • RALOX-HAIC（Hepatic Arterial Infusion Chemotherapy With Raltitrexed and Oxaliplatin
  • Type VP3/4 Portal Vein Tumor Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iparomlimab and Tuvonralimab Injection (QL1706) — DRUG
    Iparomlimab and Tuvonralimab Injection (QL1706)will be administered at a dose of 7.5 mg/kg via intravenous infusion (no premedication required). Each infusion shall last for 30 minutes (no less than 20 minutes and no more than 60 minutes), with an administration interval of 3 weeks, and one treatment cycle is defined as 3 weeks. The maximum cumulative treatment duration shall be 2 years. The administration window for QL1706 is within 7 days after hepatic arterial infusion chemotherapy. If the administration is delayed beyond the scheduled time, the dose for this cycle will be omitted, and the subsequent administration will be resumed at the original dose in accordance with the next scheduled time.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15 mg/kg via intravenous infusion (no premedication required), once every 3 weeks, with one treatment cycle defined as 3 weeks. The maximum cumulative treatment duration shall be 2 years.
  • Hepatic Arterial Infusion Chemotherapy with Raltitrexed and Oxaliplatin (RALOX-HAIC) — PROCEDURE
    RALOX regimen chemotherapy will be delivered via hepatic arterial infusion (HAIC). The procedure will be performed using the Seldinger technique for femoral artery puncture and catheterization. Digital subtraction angiography (DSA) will be conducted to identify the blood supply artery of the lesion. A conventional catheter (or a microcatheter if necessary) will be superselectively inserted into the tumor-feeding artery via the celiac trunk or superior mesenteric artery, then the catheter will be retained in the catheter sheath and fixed to the body surface before the patient is returned to the ward. In the ward, the catheter will be connected to an infusion pump for continuous infusion of the following chemotherapeutic agents: Oxaliplatin 85 mg/m² over 2 to 4 hours, and Raltitrexed 3 mg/m² over 1 to 2 hours. The catheter will be removed upon completion of chemotherapy, followed by compression bandaging for hemostasis for 6 hours.

Study Details

The goal of this prospective, single-arm, multi-center Phase II clinical trial is to evaluate the clinical efficacy and safety of QL1706 combined with bevacizumab and RALOX hepatic artery infusion chemotherapy in treating liver cancer patients with VP3/4 portal vein tumor thrombus. It will also explore molecular biomarkers that predict the efficacy of this combined therapy. The main questions it aims to answer are: What is the progression-free survival (PFS) of patients treated with this regimen? What are the objective response rate (ORR), disease control rate (DCR), and overall survival (OS) of these patients? What is the safety and tolerability profile of this combined treatment? Which molecular biomarkers can predict the efficacy of this therapy? Eligible subjects (who have signed informed consent) will receive RALOX hepatic artery infusion chemotherapy plus QL1706 (7.5mg, intravenous infusion every 3 weeks) and bevacizumab (15mg/kg, intravenous infusion every 3 weeks), with 3 weeks as one treatment cycle. Treatment will continue until a protocol-specified discontinuation event occurs. After treatment, subjects will undergo post-treatment safety follow-up and survival follow-up; those who discontinue treatment for reasons other than disease progression or death will also have tumor progression follow-up.

Key Dates

First listed
Jan 8, 2026
Start date
Dec 25, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iparomlimab and Tuvonralimab Injection (QL1706) combined with Bevacizumab plus RALOX-HAIC

Primary Outcome Measure

Progression free survival time (PFS) [ Time Frame: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 2 years) ]

Central Contacts