Combining lenvatinib, sintilimab, and SIRT for treating advanced liver cancer
Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
This study is testing a new combination of treatments for people with advanced liver cancer to see if it helps them live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, sintilimab, lenvatinib, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05992584 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a combination treatment involving lenvatinib, sintilimab, and selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC). The study will enroll 30 patients who will receive lenvatinib and sintilimab after undergoing SIRT. The primary goal is to assess progression-free survival using modified RECIST criteria, while secondary outcomes include overall survival and response rates. The treatment duration will depend on disease progression or adverse effects.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable HCC (BCLC stage B/C) who have at least one measurable untreated lesion and a Child-Pugh score of 5-7.
Not a fit: Patients with extensive liver tumor involvement or significant vascular invasion are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced liver cancer.
How similar studies have performed: While this approach is innovative, similar combinations of targeted therapies and radiation have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically * At least one measurable untreated lesion * Intrahepatic tumors can be treated with 1-2 session of SIRT * Child-Pugh score 5-7 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Life expectancy of at least 3 months * Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL * Patients with hepatitis C need to finish the anti-HCV treatment Exclusion Criteria: * tumor extent ≥70% liver occupation * Tumor thrombus involving main portal vein or both the first left and right branch of portal vein * Vena cava invasion * Central nervous system metastasis * Metastatic disease that involves major airways or blood vessels * Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC * History of organ and cell transplantation * Prior esophageal and/or gastric varices bleeding * History of hepatic encephalopathy * Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L * Prolongation of prothrombin time ≥ 4 seconds * Severe organ dysfunction (heart, lungs, kidneys) * History of malignancy other than HCC * HBsAg and anti-HCV antibody positive concurrently * Human immunodeficiency virus (HIV) infected
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mingyue Cai, Dr.
- Email: cai020@yeah.net
- Phone: +86-20-34156205
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.