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

Shanghai Zhongshan Hospital1 site in 1 country30 target enrollmentMarch 25, 2019

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: PFS
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 25, 2019

End Date

February 28, 2022

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics.
•Patients including metastasis are inoperable or unresectable. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies. Lesions should be no more than five and be able to administrate SBRT, and at least one lesion is evaluable.
•The Laboratory test results must meet the following criteria:
•neutrophils ≥1.5×109/L
•Platelets ≥75×109/L
•Hemoglobin ≥90g/L (no blood transfusion within past 14 days)
•Serum Cr ≤1.5×ULN, endogenous creatinine clearance rate \>60ml/min (Cockcroft-Gault formula)
•AST ≤2.5×ULN, ALT ≤2.5×ULN; both ALT and AST ≤5×ULN if there are liver metastasis
•TSH, FT3, FT4 are within ± 10% of the normal range
•blood coagulation functon: INR ≤2.5×ULN and APTT ≤ 1.5 ULN

Exclusion Criteria

•Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma.
•History of hepatic encephalopathy or liver transplantation
•Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included.
•Untreated hepatitis infection: HBV DNA\>2000IU/mlor104 copy/ml, HCV RNA\> 103copy/ml, both HbsAg and anti-HCV body are positive.
•Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
•In the past six months, there was a history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive intestinal resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea.
•History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
•Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated.
•Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
•Severe infections are in active stage or under clinical control. Severe infections occurred within 4 weeks before the first treatment, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia.