Combination treatment for advanced liver cancer using anti-PD-1/PD-L1 and anti-VEGF antibodies
Phase I/II Study of Anti-PD-1/PD-L1 Antibodies Combined With Anti-VEGF Antibody Treatment in Patients With Advanced-Stage Hepatocellular Carcinoma
This study is testing a new combination treatment for adults with advanced liver cancer to see if it helps improve their health and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | prednisone, nivolumab, sintilimab, toripalimab, tislelizumab, atezolizumab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06537908 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety, tolerability, and efficacy of a combination treatment involving anti-VEGF and anti-PD-1/PD-L1 antibodies in adult patients with advanced hepatocellular carcinoma (HCC). Participants will receive intravenous administration of these antibodies, with treatment continuing until disease progression, intolerable toxicity, or withdrawal of consent. The study aims to determine how well this combination therapy works in patients who have unresectable late-stage HCC, focusing on measurable lesions and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced hepatocellular carcinoma that is unresectable or has metastasized.
Not a fit: Patients with active autoimmune diseases or those who do not meet the specified organ function requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hepatocellular carcinoma, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating advanced hepatocellular carcinoma, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 years old, male or female 2. Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Patient has given written informed consent. 5. The function of important organs meets the requirements 6. Expected survival ≥12 weeks 7. Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period. Exclusion Criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3. Have clinical symptoms or disease that are not well controlled; 4. Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization; 5. Arterial/venous thrombosis in the first 6 months of randomization 6. According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.#with family or social factors, it will affect the safety of patients. 7. Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;
Where this trial is running
Shanghai
- Zhongshan Hospital Fudan university — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Qinghai Ye — Fudan University
- Study coordinator: Wenxin Xu
- Email: 22211210052@m.fudan.edu.cn
- Phone: 2164041990
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.