Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Criteria

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.

2. Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)

3. Has at least 1 measurable lesion

4. Age ≥18 years

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

6. Adequate organ function

7. Child Pugh class A

8. Life expectancy ≥12 weeks.

9. Antiviral therapy per local standard of care for hepatitis B

10. Woman of child bearing potential must have a negative pregnancy test

11. Must use acceptable form of birth control while on study

Exclusion Criteria:

1. Has previously been performed by raditotherapy for the area to be treated.

2. With extrahepatic metastasis

3. History of hepatic encephalopathy or liver transplantation

4. Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive

5. Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes

6. Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment

7. With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable

8. Evidence of active pulmonary tuberculosis (TB)

9. Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)

10. History of allergic reactions to related drugs