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New treatment option for Unresectable Hepatocellular Carcinoma
Official title Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
ClinicalTrials.gov ID: NCT05917431
What this study is testing
What is SBRT plus tislelizumab and regorafenib?
SBRT plus tislelizumab and regorafenib is an investigational medicine, being studied as a potential treatment for unresectable hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- at least one measurable lesion according to mRECIST criteria
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.