The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy.
It will also learn about the safety of donafenib combined with immunotherapy and local therapy.
The main questions it aims to answer are:
The Objective Response Rate (mRecist） and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy.
The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy.
The safety of donafenib combined with immunotherapy and local therapy in the participants.
Participants will:
Replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy (if have).
The observation period was 1 year.
Voluntarily participate in this study, sign the informed consent form, and be aged between 18 and 70 years old.
Have at least one measurable lesion.
Clinically and pathologically diagnosed with hepatocellular carcinoma and not suitable for surgical resection.
Child-Pugh liver function classification: Class A/Class B.
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).
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).
Patients with congenital or acquired immune function deficiency (such as HIV-infected individuals).
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.
Single group
Donafenib
DrugDonafenib will be taken orally twice a day, 0.2g each time.
transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy
Procedure/SurgeryEligible subjects will receive transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy as previous (if have).
PD-1,PD-L1
DrugPD-1/PD-L1 will be used as previous (if have).
Objective Response Rate (mRecist）(ORR)
According to mRECIST to evaluate the proportion of patients with CR and PR in the total number of patients.
Progression-free survival
Patients' progression-free survival after switching to the new treatment regimen is the time between the start of the change and tumor recurrence or death, whichever occurs first
Disease control rate (DCR)
Disease control rate (DCR)
Overall Survival (OS)
The time from the date of initiation of the drug donafenib until the date of death from any cause
Incidence of adverse events and serious adverse events
Incidence of adverse events and serious adverse events.
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This trial is not recruiting at the moment. You can still explore other options:
