Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917431
• Other study ID #: PKU-LiCaS2
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Oligometastatic Disease
• Unresectable Hepatocellular Carcinoma

Intervention

Combination Product:
• SBRT plus tislelizumab and regorafenib
Participants will receive SBRT plus tislelizumab and regorafenib concurrently

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	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	OS	Overall survival	From the date of treatment beginning until the date of death from any cause, assessed up to 48 months
Secondary	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	From the date of treatment beginning until the date of last follow-up, assessed up to 48 months