Actively Recruiting
Iparomlimab and Tuvonralimab (QL1706) With Bevacizumab and RALOX Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma With Vp3/4 Portal Vein Thrombosis: A Multicenter Phase II Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-01-13
38
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination therapy for liver cancer patients who have a specific type of tumor growth called VP3/4 portal vein tumor thrombus. This Phase II clinical trial aims to assess the clinical effectiveness and safety of a treatment combining QL1706, bevacizumab, and RALOX hepatic artery infusion chemotherapy. The study will also explore molecular biomarkers to predict how well patients respond to this combined therapy. Participants will receive QL1706 by intravenous infusion at a dose of 7.5 mg/kg every 3 weeks, along with bevacizumab at 15 mg/kg intravenously every 3 weeks. The RALOX chemotherapy regimen, which includes oxaliplatin and raltitrexed, will be delivered directly into the liver artery using a catheter and infusion pump. Treatment cycles last 3 weeks, and therapy may continue for up to 2 years, or until specific stopping criteria are met. After treatment ends, participants will have follow-up visits to monitor safety, survival, and tumor progression if treatment is stopped for reasons other than disease progression or death. During the study, participants will undergo various assessments including imaging to measure tumor lesions, blood tests to monitor organ function and safety, and evaluations of their overall health status and survival. Researchers will measure progression-free survival as the main outcome, along with response rates, disease control, overall survival, and treatment-related side effects. The entire study participation may last up to about 2 years, including treatment and follow-up periods.
CONDITIONS
Brief Title
QL1706 in Combination With Bevacizumab and RALOX HAIC for Hepatocellular Carcinoma With Vp3/4 PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Aged 18 years or older, male or female
- Clinically or pathologically confirmed hepatocellular carcinoma with no prior systemic anti-tumor therapy for HCC
- Presence of Type VP3 or VP4 portal vein tumor thrombosis
- At least one measurable target lesion by imaging according to RECIST v1.1 criteria
- Child-Pugh score of 7 points or less (Class A-B)
- Liver tumor with maximum diameter of 7 cm or more
- ECOG performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate vital organ function including specified blood counts and liver and kidney function
- Agreement to use reliable contraception during the trial and for 180 days after last dose if of reproductive potential
- Negative pregnancy test for women of childbearing potential within 7 days prior to first study medication
You will not qualify if you...
- Diagnosis of fibrolamellar, sarcomatoid, cholangiocellular, or mixed hepatocellular carcinoma
- Active autoimmune disease or history of autoimmune disease with potential recurrence (except controlled conditions)
- Use of immunosuppressants or systemic steroids above 10 mg prednisone equivalent within 2 weeks before study
- Current or recent interstitial lung disease or pneumonia interfering with immune-related toxicity assessment
- Active pulmonary tuberculosis
- Known hypersensitivity to study drugs or related monoclonal antibodies
- History of central nervous system metastasis or hepatic encephalopathy
- History of stem cell or organ transplantation
- Moderate to severe ascites or uncontrolled pleural or pericardial effusion
- Severe cardiovascular or cerebrovascular diseases as detailed in criteria
- Coagulation disorders or recent significant bleeding events
- History of esophageal or gastric variceal bleeding or severe varices
- Life-threatening bleeding events within 3 months prior to study
- Recent history of abdominal fistula, gastrointestinal perforation, or abscess
- Recent gastrointestinal obstruction or severe infection
- Immune deficiency such as HIV or active syphilis
- Other malignancies within 5 years except some cured localized tumors
- Recent hepatic surgery, local treatment, or investigational drug use
- Use of immunomodulatory drugs within 2 weeks prior to study
- Participation in other clinical trials within 4 weeks prior to study
- Recent live attenuated vaccines or anticipated need during study
- Major surgery within 4 weeks prior to study or planned during study
- Pregnancy or lactation or refusal to use contraception
- Other conditions or factors judged by investigator to affect study results or patient safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive Iparomlimab and Tuvonralimab (QL1706) and Bevacizumab via intravenous infusion every 3 weeks combined with Hepatic Arterial Infusion Chemotherapy (RALOX-HAIC).
Visits every 3 weeks for intravenous infusions and hepatic arterial infusion chemotherapy sessions as scheduled
Duration - 30 days
Participants are monitored for safety and adverse events for 30 days after the last dose of study treatment.
1 to 2 visits for safety assessments
Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
M
Mengya Zang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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