Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
SBRT plus tislelizumab and regorafenib
Combination productParticipants will receive SBRT plus tislelizumab and regorafenib concurrently
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: SBRT plus Tislelizumab and RegorafenibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
Progression-free survival
Time frame
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 monthsSecondary outcomes
1
OS
Overall survival
Time frame
From the date of treatment beginning until the date of death from any cause, assessed up to 48 months2
Recurrence pattern
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
Time frame
From the date of treatment beginning until the date of last follow-up, assessed up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov