Actively Recruiting
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Led by Peking University Cancer Hospital & Institute · Updated on 2023-06-23
39
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC). The main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.
CONDITIONS
Official Title
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0-1
- Clinical or pathological diagnosis of hepatocellular carcinoma (HCC)
- Unresectable locally advanced or oligometastatic HCC with 5 or fewer metastatic lesions and up to 3 metastatic organs
- At least one measurable lesion according to mRECIST criteria
- All lesions must be suitable for inclusion in radiation target volume
- Child-Pugh A or B (7 scores) liver function
- Previous systemic therapy allowed except for tislelizumab plus regorafenib
- Adequate blood and kidney function
- Life expectancy of 3 months or more
- Willing and able to provide written informed consent
You will not qualify if you...
- History of liver transplantation
- Severe cirrhosis complications including esophagogastric variceal bleeding, hepatic encephalopathy, or massive ascites
- Active autoimmune diseases or history of autoimmune disease
- HIV infection or acquired immunodeficiency syndrome (AIDS)
- Allergy to components of tislelizumab or regorafenib
- Recurrence of lesions previously treated with radiotherapy
- Radiation dose could not be safely delivered due to organ dose limits
- Intolerance to radiation or systemic treatment due to cardiac insufficiency or uncontrolled high blood pressure
- History of other malignancies except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100041
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here