Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of … (NCT07363512) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus
27 participantsStarted 2026-01-05
Plain-language summary
For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows:
First, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).
Who can participate
Age range
18 Years – 75 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
. Men aged between 18 and 75 or non-pregnant women;
. Sign the informed consent form;
. The researchers believe that the patients have the ability to comply with the research protocol;
. Hepatocellular carcinoma (HCC) is diagnosed histologically, cytologically or clinically. Patients with liver cirrhosis are clinically diagnosed according to the AASLD standard, while non-liver cirrhosis patients need to be confirmed by histology.
. Imaging examinations confirmed the presence of portal vein tumor thrombus;
. The disease is not suitable for radical surgery;
. Has not received any anti-tumor treatment in the past;
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
Objective Response Rate
Timeframe: The time from the start of the first medication to the occurrence of tumor shrinkage or disappearance and maintaining it for more than 4 weeks (up to 36 months).
. At least one measurable (measurable according to RECIST1.1) untreated lesion;
Exclusion criteria
. Current or previous history of autoimmune diseases or immune deficiencies
. History of meningitis;
. Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia can be seen on chest computed tomography (CT) images during the screening period. Radiation pneumonia has been allowed in the radiation area (fibrosis).
. Known active tuberculosis;
. Having major cardiovascular diseases (such as New York Heart Society Class II or more severe heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months prior to enrollment;
. History of congenital long QT syndrome or corrected QT interval at screening \>500ms (calculated using the Fridericia method);
. A history of uncorrectable electrolyte disorders such as serum potassium, calcium or magnesium;
. Received major surgical treatment (excluding diagnosis) within 4 weeks before enrollment or is expected to require major surgical treatment during the study period;