search
Back to results

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

Primary Purpose

Unresectable Hepatocellular Carcinoma, Oligometastatic Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SBRT plus tislelizumab and regorafenib
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT plus Tislelizumab and Regorafenib

Arm Description

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.

Outcomes

Primary Outcome Measures

PFS
Progression-free survival

Secondary Outcome Measures

OS
Overall survival
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

Full Information

First Posted
May 24, 2023
Last Updated
June 15, 2023
Sponsor
Peking University Cancer Hospital & Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05917431
Brief Title
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Official Title
Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Hepatocellular Carcinoma, Oligometastatic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT plus Tislelizumab and Regorafenib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
SBRT plus tislelizumab and regorafenib
Intervention Description
Participants will receive SBRT plus tislelizumab and regorafenib concurrently
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
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 Measure Information:
Title
OS
Description
Overall survival
Time Frame
From the date of treatment beginning until the date of death from any cause, assessed up to 48 months
Title
Recurrence pattern
Description
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
Time Frame
From the date of treatment beginning until the date of last follow-up, assessed up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dezuo Dong, MD
Phone
+8610 8819 6687
Email
dongdz13@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs