Actively Recruiting
Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
Led by Peking University Cancer Hospital & Institute · Updated on 2023-06-23
39
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining stereotactic body radiation therapy (SBRT) with immunotherapy and targeted therapy for patients who have unresectable or limited spread (oligometastatic) hepatocellular carcinoma (HCC). This phase 2 clinical trial aims to determine whether this combination can extend the time patients live without their disease worsening. The main focus is on progression-free survival (PFS) as a key outcome. Participants will receive SBRT to all visible tumors, with doses of 8 Gy given in 3 to 5 sessions. Alongside radiation, they will start systemic treatment with two drugs, tislelizumab and regorafenib, which will continue for up to 2 years or until the disease progresses, side effects become intolerable, or death occurs. Tislelizumab is administered every 21 days at a fixed dose, while regorafenib is taken for 21 days in each 28-day cycle, with possible dose adjustments for side effects. During the study, participants will be closely monitored with medical assessments to track disease status and side effects. Researchers will measure progression-free survival up to 48 months after treatment starts, along with overall survival and patterns of disease recurrence. The trial began in June 2023 and is expected to end in December 2026, offering long-term follow-up to assess outcomes and safety.
CONDITIONS
Brief 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 or 1
- Clinical or pathological diagnosis of hepatocellular carcinoma
- Unresectable locally advanced or oligometastatic HCC with up to 5 metastatic lesions in up to 3 organs
- At least one measurable lesion according to mRECIST criteria
- All lesions can be covered by radiation treatment
- Child-Pugh liver function class A or B (score up to 7)
- Patients may have received systemic therapy other than tislelizumab plus regorafenib
- Adequate blood and kidney function
- Life expectancy of at least 3 months
- Willing to participate and provide written informed consent
You will not qualify if you...
- History of liver transplantation
- Severe cirrhosis complications such as esophagogastric variceal bleeding, hepatic encephalopathy, or massive ascites
- Active or history of autoimmune diseases
- Infection with HIV or AIDS
- Allergy to tislelizumab or regorafenib
- Recurrent lesions previously treated with radiotherapy
- Radiation cannot be safely delivered due to organ dose limits
- Unable to tolerate radiation or systemic treatment due to heart failure or uncontrolled high blood pressure
- History of other cancers 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression, intolerable side effects, or death
Participants receive stereotactic body radiation therapy (SBRT) to all visible lesions combined with systemic treatment of tislelizumab and regorafenib concurrently. Tislelizumab is given every 21 days, and regorafenib is given in 21-day cycles with dose adjustments as needed. Treatment lasts up to 2 years or until disease progression, intolerable side effects, or death.
SBRT in 3 to 5 sessions; tislelizumab every 21 days; regorafenib daily for first 21 days of each 28-day cycle
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
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