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

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.

Conditions

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

Interventions

DRUG

Iparomlimab 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.

DRUG

Bevacizumab

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.

PROCEDURE

Hepatic 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Jinzhang Chen, Study Director · Nanfang Hospital, Southern Medical University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-25

Primary Completion

2027-12-30

Completion

2028-12-30

Countries

• China

Study Locations