JPRN-jRCTs031210694
Suspended
Phase 1
A single-arm phase II study of atezolizumab plus bevacizumab after stereotactic body radiation therapy in patients with unresectable hepatocellular carcinoma with macrovascular invasion - LIBERATION trial
Maeda Shin0 sites36 target enrollmentMarch 23, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- hepatocellular carcinoma
- Sponsor
- Maeda Shin
- Enrollment
- 36
- Status
- Suspended
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A. Signed informed consent Form is obtained
- •B. confirmed diagnosis of hepatocellular carcinoma by histopathological or imaging findings
- •C. Unresectable hepatocellular carcinoma not eligible for local puncture therapy (percutaneous ethanol injection, percutaneous radiofrequency ablation, microwave coagulation necrosis) or radiotherapy alone.
- •D. The diagnosis of primary hepatocellular carcinoma with either Vp3/4 or Vv2/3 according to the 6th edition of the Hepatocellular Carcinoma Treatment Guidelines.
- •E. The following criteria of prior systemic therapy for hepatocellular carcinoma are met.
- •(i) Safety part: No prior systemic therapy for HCC or Second\-line systemic therapy after sorafenib or lenvatinib without Vp3/4 or Vv2/3 on imaging findings at the start of the first\-line systemic therapy.
- •(ii) Phase II part: No prior systemic drug therapy for hepatocellular carcinoma
- •F. At least one measurable (per RECIST v1\.1\) lesion within 28 days prior to enrollment
- •G. Tumor evaluation by contrast\-enhanced CT or MRI is available
- •H. ECOG Performance Status of 0 or 1
Exclusion Criteria
- •A. Tumour invasion / tumour thrombosis in the splenic vein, superior mesenteric vein, or right atrium on imaging studies within 28 days prior to enrolment
- •B. History of hepatic encephalopathy within 180 days prior to enrollment
- •C. History of cerebral meningitis and tumour invasion of the central nervous system
- •D. Active or history of autoimmune disease requiring systemic treatment (steroids or immunosuppressive drugs)
- •E. A history of active primary immunodeficiency
- •F. Active or history of idiopathic pulmonary fibrosis, drug\-induced pneumonia, radiation pneumonitis, idiopathic pneumonia or severe emphysema
- •G. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable
- •angina within 180 days prior to enrollment
- •H.Thrombosis or embolism within 180 days prior to enrolment.
- •I. Clinically uncontrolled hypertension
Outcomes
Primary Outcomes
Not specified
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