Oligometastatic Disease, Unresectable Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTSBRT plus tislelizumab and regorafenib
Participants will receive SBRT plus tislelizumab and regorafenib concurrently
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years * Eastern Cooperative Oncology Group performance status of 0-1 * clinical or pathological diagnosis of HCC * with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain) * at least one measurable lesion according to mRECIST criteria * all lesions could be included in radiation target volume * Child-Pugh A or B (7 scores) liver function * patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib * adequate hematological and renal function * life expectancy ≥ 3 months； * willing to participate in the study and give written informed consent
Exclusion criteria
* a history of liver transplantation * with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites * with active autoimmune diseases or a history of autoimmune disease * with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) * allergic to the ingredient of tislelizumab or regorafenib * with recurrent lesions treated with radiotherapy previously * prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR) * intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure * a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From the date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From the date of treatment beginning until the date of death from any cause, assessed up to 48 months | Overall survival |
| Recurrence pattern | From the date of treatment beginning until the date of last follow-up, assessed up to 48 months | Number of participants with recurrence, which will be classified according to site of recurrence (specific organs), time interval between treatment beginning and recurrence, the relationship with the area of irradiation (in-field/out field), and whether new lesion(s) according to mRECIST criteria |
Countries
China
Outcome results
None listed