To hear about similar clinical trials, please enter your email below
Trial Title:
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
NCT ID:
NCT05917431
Condition:
Unresectable Hepatocellular Carcinoma
Oligometastatic Disease
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
SBRT plus tislelizumab and regorafenib
Description:
Participants will receive SBRT plus tislelizumab and regorafenib concurrently
Arm group label:
SBRT plus Tislelizumab and Regorafenib
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100041
Country:
China
Status:
Recruiting
Contact:
Last name:
Dezuo Dong, MD
Phone:
+8610 8819 6687
Email:
dongdz13@163.com
Start date:
June 2023
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05917431
