Unresectable Hepatocellular CarcinomaPhase 2NCT05917431
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
A Phase 2 study testing SBRT plus tislelizumab and regorafenib in people with Unresectable Hepatocellular Carcinoma and Oligometastatic Disease, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma, Oligometastatic Disease
- What is being tested?
- SBRT plus tislelizumab and regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100041
Dezuo Dong, MD, +8610 8819 6687, dongdz13@163.com
About this study
Official title: Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
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.
- Being tested
- SBRT plus tislelizumab and regorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT plus tislelizumab and regorafenibCombination product
Participants will receive SBRT plus tislelizumab and regorafenib concurrently
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: SBRT plus tislelizumab and regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 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
Overall survival
Measured: From the date of treatment beginning until the date of death from any cause, assessed up to 48 months
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
Measured: From the date of treatment beginning until the date of last follow-up, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study startJun 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang weihu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917431
- Sponsor's protocol ID
- PKU-LiCaS2
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05917431
- Acronym / sponsor ID
- PKU-LiCaS2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT plus Tislelizumab and Regorafenib | Experimental | Combination Product: SBRT plus tislelizumab and regorafenibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT plus tislelizumab and regorafenibParticipants will receive SBRT plus tislelizumab and regorafenib concurrently | Combination product | SBRT plus Tislelizumab and Regorafenib |
Primary outcome
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
Progression-free survival
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT plus tislelizumab and regorafenib in people with Unresectable Hepatocellular Carcinoma and Oligometastatic Disease, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.