Actively Recruiting
QL1706 in Combination With Bevacizumab and RALOX HAIC for Hepatocellular Carcinoma With Vp3/4 PVTT
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-01-13
38
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Signed informed consent to participate in the study
- Age 18 years or older, any gender
- Clinically or pathologically confirmed hepatocellular carcinoma with no prior systemic anti-tumor treatments
- Presence of type VP3 or VP4 portal vein tumor thrombosis
- At least one measurable tumor lesion by imaging that meets RECIST v1.1 criteria
- Child-Pugh liver function score of 7 points or less (Class A-B)
- Liver tumor maximum diameter of 7 cm or larger
- ECOG performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate vital organ function based on blood counts and laboratory tests
- Agreement to use reliable contraception during the study and for 180 days after last dose if of reproductive potential
- Negative serum pregnancy test within 7 days before first treatment if female of childbearing potential
You will not qualify if you...
- Fibrolamellar, sarcomatoid, cholangiocellular, or mixed hepatocellular carcinoma
- Active or history of autoimmune diseases with potential recurrence, except certain controlled conditions
- Use of immunosuppressants or systemic hormonal therapy for immunosuppression within 2 weeks before first dose
- Current or recent interstitial lung diseases or pneumonia that interfere with treatment evaluation
- Active pulmonary tuberculosis
- Known severe allergic reactions to study drugs or similar agents
- History of central nervous system metastasis or hepatic encephalopathy
- Prior stem cell or organ transplantation
- Moderate to severe ascites or uncontrolled pleural/pericardial effusion
- Serious cardiovascular or cerebrovascular diseases or abnormal heart rhythms
- Significant bleeding disorders or recent major bleeding events
- Recent history of gastrointestinal bleeding or high bleeding risk due to portal hypertension
- Severe infections requiring hospitalization or active infections needing antibiotics
- Known immune deficiency or active syphilis
- Other cancers within 5 years except certain cured localized tumors
- Recent liver surgery, local cancer treatments, or investigational drug use
- Recent use of immunomodulatory drugs or live vaccines
- Major surgery within 4 weeks before first dose or planned major surgery during study
- Pregnant or breastfeeding women, or women unwilling to use contraception
- Other conditions that may impact study results or participant safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
M
Mengya Zang
CONTACT
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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