NCT03857815

Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Hepatocellular Carcinoma

A Phase II Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anti-PD-1 Antibody （IBI308） in Patients With Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.

Detailed description

Stereotactic Body Radiation Therapy (SBRT) is an acceptable option for HCC patients not amenable to surgery or transplantation or manifested with oligometastasis. Recent studies have shown that SBRT plus immune checkpoint inhibitors may potentiate the effect of RT on tumor cell killing. The objective of this study is to evaluate the efficacy and safety of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	anti-PD-1 antibody	In patients with inoperable hepatocellular carcinoma or recurrence after local or regional therapy, stereotactic body radiation therapy will be combined with anti-PD-1 antibody. Stereotactic body radiation therapy: SBRT is delivered to 1\~5 Evaluable lesions of liver, lung, bone, brain or lymph nodes in limited fractions . Anti-PD-1 treatment: anti-PD-1 antibody (IBI308) is injected intravenously 200mg every three weeks.

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-09-30
• Completion: 2022-02-28
• First posted: 2019-02-28
• Last updated: 2019-03-19

Locations

1 site across 1 country: China