Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Recurrent Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Aug 9, 2023
  • participants needed
    46
  • sponsor
    Sun Yat-sen University
Updated on 12 September 2021

Summary

The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced recurrent hepatocellular carcinoma.

Details
Condition Recurrent Hepatocellular Carcinoma
Treatment Sintilimab and Bevacizumab Combined with Radiotherapy
Clinical Study IdentifierNCT05010434
SponsorSun Yat-sen University
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 18-75 years
ECOG (Eastern Cooperative Oncology Group) 0-1
Locally advanced or advanced recurrent hepatocellular carcinoma (HCC) that cannot be surgically removed
Have not received anti-tumor system therapy
At least 1 measurable lesion (according to RECIST 1.1)
Child-Pugh Class A
At least 12 weeks of life expectancy
Adequate hematologic, hepatic and renal function: Hb 90g/L, ANC(absolute neutrophil count) 1.5x10^9/L, PLT(platelet count) 60 x10^9/L, ALT(alanine aminotransferase) and AST(aspartate aminotransferase) 3ULN(upper limit of normal), total bilirubin 1.5ULN, serum creatinine 1.5ULN, albumin 30g/L
Contraception during the study
Willing to join the study and sign informed consent

Exclusion Criteria

HCV (hepatitis C virus) infection
History of allergy to anti-PD-1 (PD-1, programmed cell death protein 1) monoclonal antibody and anti-VEGF (VEGF, vascular endothelial growth factor) monoclonal antibody
Have other malignant tumors within 5 years, except for fully treated skin basal cell cancer and cervical cancer
Poor blood pressure control. In the case of taking medication, systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg
Received radiotherapy for liver disease
History of hepatic encephalopathy
Received transplantation
Severe pleural effusion, ascites or pericardial effusion
History of autoimmune diseases and autoimmune deficiency
Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration
Active infections that require systemic treatment, such as active tuberculosis
History of idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia or idiopathic pneumonia, or active pneumonia found in chest CT examination
Severe bleeding
Esophageal and gastric varices with high risk of bleeding and not fully treated; rupture of esophageal and gastric varices occurred within 6 months before the first administration
Required daily treatment with non-steroidal anti-inflammatory drugs (NSAID)
Accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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