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Recruiting NCT05917431

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

Phase II Interventional Unresectable Hepatocellular Carcinoma Oligometastatic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT plus tislelizumab and regorafenib.
Who it may be relevant to
Registry conditions: Unresectable Hepatocellular Carcinoma, Oligometastatic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Combination product SBRT plus tislelizumab and regorafenib
    Participants will receive SBRT plus tislelizumab and regorafenib concurrently

Primary outcome measures

  • PFS [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 months]
Secondary outcome measures (2)
  • OS [Time frame: From the date of treatment beginning until the date of death from any cause, assessed up to 48 months]
  • Recurrence pattern [Time frame: From the date of treatment beginning until the date of last follow-up, assessed up to 48 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Cancer Hospital — Beijing

Identifiers

NCT: NCT05917431 · PKU-LiCaS2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗