The Combination of Radiotherapy With Immunotherapy and Potential Predictive Biomarkers for Treatment of Non-Small Cell Lung Cancer Patients.
Lu Meng, Jianfang Xu, Ying Ye...
https://pubmed.ncbi.nlm.nih.gov/34621270Actively Recruiting
Phase Not Applicable
Age: 19Years - 80Years
All Genders
ID06595108
Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
Led by Yonsei University · Updated on 2024-11-01
33
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of atezolizumab and bevacizumab with stereotactic body radiotherapy (SBRT) for patients with advanced hepatocellular carcinoma. This study aims to improve the treatment response rate of the current first-line chemotherapy, which has shown low response rates. Participants have advanced liver cancer that cannot be operated on and are eligible for this combination therapy. Participants will receive SBRT targeting one to five sites of primary or metastatic cancer lesions within two months before or after starting the atezolizumab-bevacizumab combination therapy. The study includes several visits: screening, during and after SBRT, chemotherapy cycles, and follow-up visits lasting up to 36 months to monitor treatment effects and safety. During the study, participants will undergo medical history reviews, physical exams, imaging tests like CT or MRI, blood tests including tumor markers and biomarkers, stool microbiota analysis, and quality of life questionnaires. Researchers will monitor adverse events and assess progression-free survival at 6 months as the primary outcome, alongside secondary outcomes such as overall survival, tumor response, and safety over 36 months.
CONDITIONS
Brief Title
Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Age: 19Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 19 to 80 years old
- Liver function classified as Child-Pugh class A
- ECOG performance status of 0 or 1
- Clinically or pathologically diagnosed with hepatocellular carcinoma
- Advanced hepatocellular carcinoma that cannot be treated with surgery
- Eligible to receive radiotherapy within dose limits for normal organs and lesion size
You will not qualify if you...
- Presence of brain metastases
- History of other malignancies within the last 5 years except certain low-risk cancers
- High risk of untreated gastric or esophageal varices or bleeding
- Serious uncontrolled medical conditions
- Previous liver transplant surgery
- Autoimmune liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 9 weeks
Participants receive stereotactic body radiotherapy and atezolizumab-bevacizumab combination therapy for advanced hepatocellular carcinoma.
4 visits during treatment including baseline, during radiotherapy, 1 week after radiotherapy, and after 2 cycles of chemotherapy
Follow-up
Duration - 3 to 36 months
Participants are monitored for adverse events, treatment effectiveness, and quality of life after completing treatment.
Regular visits approximately monthly to every few months during follow-up
Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, South Korea, 365
Actively Recruiting
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Research Team
H
Hwakyung BYUN, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Hwa Kyung Byun, Nalee Kim, Sangjoon Park...
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Willemijn S M E Theelen, Heike M U Peulen, Ferry Lalezari...
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