Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy

Launched by TONGJI HOSPITAL · Jul 4, 2024

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ClinConnect Summary

This clinical trial is investigating a medication called donafenib, used alone or in combination with immunotherapy and local treatments, to help patients with unresectable hepatocellular carcinoma (a type of liver cancer) that hasn't improved with previous therapies. The main goals of the study are to see how well this treatment works in shrinking tumors and extending the time patients live without their cancer worsening. Researchers will also assess how safe the combination of donafenib, immunotherapy, and local therapy is for patients.

To participate in this trial, you must be between 18 and 70 years old and have at least one measurable tumor. You should have been diagnosed with liver cancer that cannot be surgically removed and have already tried other targeted therapies. If you have hepatitis B or C, you will need to be on antiviral treatment. During the study, you will continue your existing immunotherapy and local treatment while adding donafenib. The observation period for the trial will last one year, and it is not yet open for recruitment, so there’s still time to learn more about it.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate in this study, sign the informed consent form, and be aged between 18 and 70 years old.
• • 2. Have at least one measurable lesion.
• • 3. Clinically and pathologically diagnosed with hepatocellular carcinoma and not suitable for surgical resection.
• • 4. Child-Pugh liver function classification: Class A/Class B.
• • 5. Have previously received targeted therapy (excluding donafenib) in combination or not in combination with immunotherapy, locoregional therapy (transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC)), and have clear tumor progression assessed by two clinicians using the RECIST criteria.
• • 6. If infected with hepatitis B virus (HBV), such as positive for HBsAg, HBV-DNA must be tested, and HBV-DNA must be less than 500 IU/mL; for patients with HBV-DNA greater than 500 IU/mL, at least one week of antiviral treatment is required before randomization (only nucleoside analogs such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide tablets are allowed), and the viral copy number should be reduced by more than 10 times compared to before treatment. For HBV infected individuals, antiviral treatment must be received throughout the study period. Patients who are positive for hepatitis C virus (HCV)-RNA must receive antiviral treatment according to the treatment guidelines.
• • 7. Serum bilirubin should be ≤2.0 times the upper limit of normal (ULN); this condition does not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction must be resolved before enrollment in the study.
• • 8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤2.5 times the ULN. For patients with liver metastases, ALT and AST should be ≤5 times the ULN.
• Exclusion Criteria:
• • 1. Have an active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism).
• • 2. Use of immunosuppressants or systemic corticosteroid therapy for the purpose of immunosuppression within 2 weeks prior to treatment (dose \>10mg/day prednisone or other equivalent efficacy corticosteroids).
• • 3. Patients with congenital or acquired immune function deficiency (such as HIV-infected individuals).
• • 4. Have a history of other primary malignant tumors, except for the following situations: malignant tumors treated with curative intent, known to be inactive for ≥5 years prior to the first study intervention and with a low potential risk of recurrence; basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or malignant melanoma in situ that has been treated with potentially curative intent; or in situ cancer that has been adequately treated with no evidence of disease.
• • 5. Known allergy to any study drug or excipients.
• • 6. Participation in other drug clinical studies within the past 4 weeks.
• • 7. Pregnant or lactating women.