About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Radiotherapy combined with tislelizumab and anlotinib
Combination productRadiotherapy was performed using conventional fractionation. The PTV of the primary tumor and portal vein tumor thrombus was DT45-50Gy/25f, and the GTV was simultaneously pushed at DT50-60Gy/25f, Tislelizumab 200mg IV Q3W Anlotinib 12MG PO QD for two weeks followed by a one-week break Q3W
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate
The proportion of patients whose tumor volume has shrunk by more than 20% and can be maintained for more than 4 weeks.
Secondary outcomes
Overall Survival
Progression-Free Survival
Disease Control Rate
The percentage of patients whose tumors shrank or remained stable over a period of time.
Duration of response
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: