Combining sintilimab and bevacizumab with liver support for advanced liver cancer
A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma
This study is testing a new combination treatment with sintilimab and bevacizumab, along with liver support, to see if it helps people with advanced liver cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 79 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | sintilimab, bevacizumab |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05616390 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a combination treatment involving sintilimab and bevacizumab, along with liver protective support therapy, for patients with unresectable hepatocellular carcinoma. The study focuses on individuals with advanced liver cancer who have specific health criteria, including Child-Pugh grade B and ECOG performance status of 2. Participants will be monitored for treatment efficacy and safety outcomes over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20-79 with advanced unresectable hepatocellular carcinoma and specific health conditions.
Not a fit: Patients who have previously received certain immunotherapies or have active autoimmune diseases may not benefit from this study.
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 the combination of these therapies is being explored, similar approaches in treating hepatocellular carcinoma have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology * Age 20-79 * At least one measurable lesion defined in RECIST version 1.1 * Child Pugh grade B * ECOG PS score 2 * The expected life is at least 90 days Exclusion Criteria: * Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells * Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment * Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases * History of pleural or pericardial adhesions within 28 days before enrollment * HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive * Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years) * Brain or meningeal metastasis (unless asymptomatic and does not require treatment) * Uncontrollable or serious cardiovascular disease.
Where this trial is running
Tianjin, Tianjin
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Huikai Li
- Email: lihuikai@tjmuch.com
- Phone: 862223340123
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.