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 range18 Years – 75 Years
SexALL
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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;
✓. At least one measurable (measurable according to RECIST1.1) untreated lesion;
Exclusion criteria
✕. Current or previous history of autoimmune diseases or immune deficiencies
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).
✕. 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;