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

Phase 2

Recruiting

• Conditions: Unresectable Hepatocellular Carcinoma; Oligometastatic Disease
• Interventions: Combination Product: SBRT plus tislelizumab and regorafenib

• Registration Number: NCT05917431
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Status Verified: 2023-06
• Study Start: 2023-06
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT plus Tislelizumab and Regorafenib	SBRT plus tislelizumab and regorafenib	Participants will receive SBRT (8 Gy × 3-5 fractions) to all visible lesions. Systemic treatment (tislelizumab and regorafenib) will start concurrently and last for 2 years, or until disease progression, intolerable side-effects or death. Tislelizumab will be delivered every 21 days at a dose of 200mg, and regorafenib will be given at a dose of 120mg for the first 21 days of a 28-day cycle. Appropriate dose adjustments of regorafenib will be made if side-effects are intolerable, while the dose of tislelizumab should not be adjusted, but could be paused.

Primary Outcome Measures

Name	Time	Method
PFS	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	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	From the date of treatment beginning until the date of death from any cause, assessed up to 48 months	Overall survival
Recurrence pattern	From the date of treatment beginning until the date of last follow-up, assessed up to 48 months	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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China