Clinical trial NCT05917431: Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Official title: Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Unresectable Hepatocellular Carcinoma
Oligometastatic Disease
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: 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
Secondary outcomes:
measure: OS
timeFrame: From the date of treatment beginning until the date of death from any cause, assessed up to 48 months
measure: Recurrence pattern
timeFrame: From the date of treatment beginning until the date of last follow-up, assessed up to 48 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References: