Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma

Launched by QIANFOSHAN HOSPITAL · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called conversion therapy for patients with a type of liver cancer known as hepatocellular carcinoma (HCC) that cannot be removed by surgery. The goal is to see how effective and safe this therapy is for people whose cancer is considered initially unresectable, meaning it can't be surgically removed at the beginning of treatment. The trial is currently recruiting patients who are 18 years or older and have confirmed advanced HCC with at least one measurable tumor. To qualify, participants should not have received certain prior immunotherapies and should have a good performance status, meaning they are generally able to take care of themselves.

If you or a loved one are interested in participating, you should be aware that there are some criteria that would exclude you from the study, such as having certain autoimmune diseases, receiving live vaccines recently, or having a history of immunodeficiency. Participants will receive the conversion therapy and will be monitored for safety and effectiveness throughout the trial. This study is important because it may help find new ways to treat liver cancer that can't currently be surgically removed, potentially improving outcomes for patients facing this challenge.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 18 years old, gender is not limited;
• • Patients with radiographically or pathologically confirmed, unresectable advanced hepatocellular carcinoma;
• • At least one measurable lesion according to the mRECIST criteria as the target lesion;
• • No prior immunotherapy, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies;
• • Patients with an ECOG score of 0-2 were included according to the activity status score scale developed by the Eastern Cooperative Oncology Group (ECOG) in the United States;
• • Child-Pugh liver function is graded as A or B.
• Exclusion Criteria:
• • Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases;
• • Have other malignancies;
• • Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or other patients who are considered by the investigator to have an impact on study treatment;
• • Long-term heavy use of corticosteroids or other immunomodulators;
• • Serious illness in combination with other systems;
• • Received a live or attenuated vaccine within 30 days prior to the first dose, or plans to receive a live or attenuated vaccine during the study, excluding the new crown vaccine;
• • Known human immunodeficiency virus (HIV) infection;
• • Have participated in other therapeutic clinical studies;
• • Incomplete clinical data.