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Recruiting Phase 2

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

NCT05917431 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-06
Last updated
2023-06-23

Condition(s) studied

Unresectable Hepatocellular CarcinomaOligometastatic Disease

Investigational drug(s) / intervention(s)

SBRT plus tislelizumab and regorafenib

SBRT plus tislelizumab and regorafenib: Participants will receive SBRT plus tislelizumab and regorafenib concurrently

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05917431 on ClinicalTrials.gov ↗ ← All trials in China