Combination treatment for advanced liver cancer
Sintilimab, Bevacizumab 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 advanced liver cancer to see if it helps patients live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, sintilimab, bevacizumab, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06397222 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a combination treatment involving sintilimab, bevacizumab, and selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC). It is a single-center, prospective study enrolling 23 patients who will receive the treatments over a period of up to 24 months. The primary endpoint is progression-free survival, while secondary endpoints include overall survival and response rates.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable intermediate-advanced HCC who have at least one measurable untreated lesion and meet specific health criteria.
Not a fit: Patients with extensive liver 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: Other studies have shown promising results with similar combination therapies in treating advanced liver cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically * At least one measurable untreated lesion * Intrahepatic tumors can be treated with 1-2 sessions 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 branches 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 for HCC * History of organ and cell transplantation * Prior esophageal and/or gastric varices bleeding * Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy * Evidence of portal hypertension with high risk of bleeding * Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment * Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment * Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy * Peripheral blood white blood cell count \<3×10\^9/L and platelet count \<50×10\^9/L * Prolonged prothrombin time \>4 seconds * Severe organ (heart, lung, kidney) dysfunction * History of other malignancies * Co-infection with hepatitis B and C viruses * Human immunodeficiency virus infection * Pregnant or lactating patients
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.