Study on GT90001 and Nivolumab for Patients with Advanced Liver Cancer

Inclusion Criteria

• Must have advanced liver cancer that cannot be treated with surgery or local therapies, or cancer that has worsened after such treatments.
• Have a specific stage of liver cancer (BCLC Stage C or certain BCLC Stage B) that cannot be treated with local therapies.
• Have not responded to or cannot tolerate first-line immune checkpoint inhibitor treatments.
• Have a Child-Pugh score of 6 or less, indicating good liver function.
• Have a performance status score of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
• Have a life expectancy of more than 3 months.
• Have good function of important organs as confirmed by tests.

Exclusion Criteria

• Have a tumor blocking major blood vessels or involving the heart.
• Have untreated or high-risk varices (enlarged veins) that could bleed.
• Have a history of brain-related issues like encephalopathy or cancer spread to the brain.
• Have had a solid organ or blood cell transplant.
• Have had certain liver treatments within 4 weeks before starting the study.
• Have had previous treatment with certain drugs like TKIs or immune checkpoint inhibitors recently.
• Have active infections like hepatitis B and C, or tuberculosis.
• Have serious wounds, ulcers, or untreated bone fractures.
• Have had recent blood clots or embolic events unless on stable anticoagulation therapy.
• Have another progressing cancer or have needed treatment for another cancer in the past 3 years.
• Have a history of lung inflammation that required steroids or have current lung issues.
• Have any other serious health condition that makes participation unsafe.