Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Radiotherapy combined with tislelizumab and anlotinib

    Combination product

    Radiotherapy 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

27 Participants
are divided into 1 treatment group
Group A: Radiotherapy combined with tislelizumab and anlotinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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).

Secondary outcomes

1

Overall Survival

Time frame
up to 36 months
2

Progression-Free Survival

Time frame
up to 36 months
3

Disease Control Rate

The percentage of patients whose tumors shrank or remained stable over a period of time.

Time frame
up to 36 months
4

Duration of response

Time frame
up to 36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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