Combining radiation therapy with immunotherapy and targeted therapy for liver cancer
Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
This study is testing whether combining a type of radiation therapy with two cancer drugs can help people with hard-to-treat liver cancer live longer without their disease getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | tislelizumab, radiation, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05917431 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial aims to evaluate the effectiveness and safety of combining stereotactic body radiation therapy (SBRT) with the immunotherapy drug tislelizumab and the targeted therapy regorafenib in patients suffering from unresectable or oligometastatic hepatocellular carcinoma (HCC). Participants will receive SBRT targeting all visible lesions while concurrently undergoing systemic treatment with the two therapies. The primary objective is to determine if this combination can prolong progression-free survival (PFS) in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable or oligometastatic HCC and a performance status of 0-1.
Not a fit: Patients with severe cirrhosis complications or a history of liver transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced liver cancer.
How similar studies have performed: While the combination of SBRT with immunotherapy and targeted therapy is a novel approach, similar studies have shown promising results in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.