NCT05917431RecruitingPhase 2
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC
Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 23 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 24 May 2023
- Start date
- Jun 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05917431
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 39
- From Jun 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- with recurrent lesions treated with radiotherapy previously
- prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)
Other illness
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.