RecruitingPhase 2NCT07327788

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

Iparomlimab and Tuvonralimab (QL1706) With Bevacizumab and RALOX Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma (HCC) With Vp3/4 Portain Vein Thrombosis : A Prospective, Multicenter, Phase II Study

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

38 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (QL1706), the anti-blood vessel drug bevacizumab, and a chemotherapy delivered directly into the liver's blood supply (HAIC) for patients with liver cancer complicated by a blood clot in the main liver vein (portal vein tumor thrombosis). This is a particularly aggressive form of liver cancer that is difficult to treat. **You may be eligible if...** - You are 18 or older and have been diagnosed with liver cancer (hepatocellular carcinoma) - Your cancer has spread into the portal vein (the main vein feeding the liver), specifically type VP3 or VP4 portal vein tumor thrombosis - You have not received any prior systemic (whole-body) treatment for your liver cancer - Your main liver tumor is at least 7 cm in diameter - You are in reasonably good health with adequate liver, kidney, and blood function - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have already received systemic cancer therapy (chemotherapy, immunotherapy, or targeted therapy) - Your liver is severely failing - You do not have measurable tumor on imaging - You have serious infection or other major health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab and Tuvonralimab Injection (QL1706)

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.

DRUGBevacizumab

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.

PROCEDUREHepatic Arterial Infusion Chemotherapy with Raltitrexed and Oxaliplatin (RALOX-HAIC)

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.