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

NCT05917431 | Recruiting Phase 2 DMC

• 1 other identifier: PKU-LiCaS2
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Hepatocellular Carcinoma; Oligometastatic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• OS

  From the date of treatment beginning until the date of death from any cause, assessed up to 48 months

• Recurrence pattern

  From the date of treatment beginning until the date of last follow-up, assessed up to 48 months

Study Arms (1)

SBRT plus Tislelizumab and Regorafenib

EXPERIMENTAL

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.

Combination Product: SBRT plus tislelizumab and regorafenib

Interventions

SBRT plus tislelizumab and regorafenib COMBINATION_PRODUCT

Participants will receive SBRT plus tislelizumab and regorafenib concurrently

SBRT plus Tislelizumab and Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100041, China

RECRUITING

MeSH Terms

Interventions

Radiosurgery; tislelizumab; regorafenib

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 23, 2023
• Study Start: June 1, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)