Combining Tislelizumab and TKI for Liver Cancer Treatment
Tislelizumab Plus Tyrosine Kinase Inhibitor (TKI) as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation: A Prospective Cohort Study
This study is testing if combining an immunotherapy drug with another cancer treatment can help adults with liver cancer who are at high risk of it coming back after surgery feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, tislelizumab, immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06059885 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of combining tislelizumab, an immunotherapy drug, with a tyrosine kinase inhibitor (TKI) as adjuvant therapy for patients with hepatocellular carcinoma (HCC) who are at high risk of recurrence after curative ablation. The study aims to compare this combination treatment against active surveillance to determine if it can reduce recurrence rates and improve patient outcomes. Eligible participants are adults diagnosed with HCC who have undergone successful ablation and meet specific high-risk criteria. The trial is designed as an open-label, prospective cohort study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of HCC who have undergone curative ablation and are at high risk of recurrence.
Not a fit: Patients with concurrent primary malignant tumors or those who have previously received targeted or immune checkpoint therapy for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence rates of liver cancer in high-risk patients.
How similar studies have performed: Previous studies have shown promise with adjuvant immunotherapy in similar contexts, but the combination of tislelizumab and TKI specifically is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria: solitary tumor \>2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm； poor tumor differentiation； macrovascular invasion of the portal vein(Vp1/Vp2) ； the absence or infiltration of a tumor capsule ； AFP≥32ng/ml； HBV DNA ≥105IU/ml； history of recurrence after curative treatment； family history of tumors. Exclusion Criteria: Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;
Where this trial is running
Beijing, Beijing
- 302 Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Fanping Meng — 302 Hospital Beijing, China
- Study coordinator: Fanping Meng
- Email: drmengfanping@126.com
- Phone: 010-66933219
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.