A Clinical Study Evaluating HAIC Combined With Iparomlimab and Tuvonralimab Injection Plus Bevaci… (NCT07119931) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Clinical Study Evaluating HAIC Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)
34 participantsStarted 2025-09-10
Plain-language summary
Major Objectives To evaluate the efficacy of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab as a conversion therapy in patients with potentially resectable HCC, assessed by the conversion resection rate.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance;
. Age ≥ 18 years, regardless of gender;
. HCC confirmed histologically/cytologically or meeting the clinical diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition), with no evidence of extrahepatic metastasis;
. Potentially resectable HCC must meet ALL of the following criteria:
. No prior systemic therapy for HCC (including investigational systemic agents);
. Child-Pugh score class A or well-compensated class B (score ≤7);
. Subjects with HBV or HCV infection must meet the following criteria:
Exclusion criteria
. Pregnant or lactating women;
. Histologically/cytologically confirmed HCC containing fibrolamellar, sarcomatoid, or cholangiocarcinoma components;
. History of other primary malignancies within 5 years (except adequately treated and stable non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conversion resection rate
Timeframe: up to 12 month
Trial details
NCT IDNCT07119931
SponsorTianjin Medical University Cancer Institute and Hospital
. Current or prior central nervous system (CNS) metastases or leptomeningeal metastasis;
. Bleeding tendency, high bleeding risk, or coagulation dysfunction: including but not limited to thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening; and/or history of hemoptysis (≥2.5 ml bright red blood per episode) within 3 months prior to screening; current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for treatment; significant risk of gastrointestinal bleeding as judged by the investigator;
. Presence of unhealed fractures, wound dehiscence requiring intervention, wound healing complications; tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months prior to screening;
. Major surgery within 4 weeks before first dose (defined as Grade III or higher surgical procedures, excluding central venous catheter placement, tumor biopsy, etc.) or significant trauma with incomplete recovery;
. Significant cardiovascular diseases (e.g., NYHA Class II or higher heart failure, myocardial infarction, or cerebrovascular events within 3 months before initiating study treatment), unstable arrhythmias, or unstable angina;