Overview

Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Recurrent Hepatocellular Carcinoma

Status:
Recruiting

Trial end date:
2023-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sun Yat-sen University

Collaborator:

Innovent Biologics (Suzhou) Co. Ltd.

Treatments:

Bevacizumab

Criteria

Inclusion Criteria:

1. Age: 18-75 years;

2. ECOG (Eastern Cooperative Oncology Group) 0-1;

3. Locally advanced or advanced recurrent hepatocellular carcinoma (HCC) that cannot be
surgically removed;

4. Have not received anti-tumor system therapy;

5. At least 1 measurable lesion (according to RECIST 1.1);

6. Child-Pugh Class A;

7. At least 12 weeks of life expectancy;

8. 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) ≤3×ULN(upper limit of normal), total bilirubin
≤1.5×ULN, serum creatinine ≤1.5×ULN, albumin ≥ 30g/L;

9. Contraception during the study;

10. Willing to join the study and sign informed consent.

Exclusion Criteria:

1. HCV (hepatitis C virus) infection.

2. 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.

3. Have other malignant tumors within 5 years, except for fully treated skin basal cell
cancer and cervical cancer;

4. Poor blood pressure control. In the case of taking medication, systolic blood
pressure>140mmHg or diastolic blood pressure>90mmHg.

5. Received radiotherapy for liver disease.

6. History of hepatic encephalopathy.

7. Received transplantation.

8. Severe pleural effusion, ascites or pericardial effusion.

9. History of autoimmune diseases and autoimmune deficiency.

10. Receiving systemic glucocorticoid therapy or any other form of immunosuppressive
therapy within 7 days before the first administration.

11. Active infections that require systemic treatment, such as active tuberculosis.

12. History of idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia or
idiopathic pneumonia, or active pneumonia found in chest CT examination.

13. Severe bleeding.

14. 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.

15. Required daily treatment with non-steroidal anti-inflammatory drugs (NSAID).

16. Accompanying diseases that seriously endanger the safety of the patient or affect the
completion of the study.