Hepatocellular carcinoma
Conditions
Interventions
Hepatic artery infusion chemotherapy plus Regorafenib:Hepatic artery infusion chemotherapy (OXA 85 mg/m2, LV 400 mg/m2, 5-Fu 2800 mg/m2) plus Regorafenib(160mg, qd)
Regorafenib:Regorafenib(160mg, qd)
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Age = 18 years old ? Signed a written informed consent and was able to comply with the treatment and visit procedures stipulated in the research program. ? Meets the clinical diagnostic criteria of HCC confirmed by radiology, histology or cytology. ? BCLC stage C HCC. ? Has previously received first-line systemic therapy for advanced HCC. ? Baseline imaging examination showed at least one measurable lesion conforming to RECIST 1.1 standard. ? Has no liver cirrhosis and the Child-Pugh classification is Grade A or B, or has liver cirrhosis but the Child-Pugh classification is Grade A. ? ECOG score 0-2 ? Good organ and bone marrow function.
Exclusion criteria
Exclusion criteria: ? Participating in other therapeutic clinical trials within 28 days before the start of treatment. ? Previously received HAIC treatment with Rigofenib. ? Those who have received or plan to undergo liver transplantation. ? Those who had permanently stopped using sorafenib because of toxicity. ? Those with clinical significant cardiovascular diseases. ? Those with active bleeding or has a risk of bleeding. ? Those with recent, persistent or active infection. ? Those with serious, unhealed injurys, or abdominal wall or gastrointestinal fistula, gastrointestinal perforation, abdominal abscess, unhealed gastrointestinal ulcer, or gastrointestinal obstruction within 6 months before the start of treatment. ? Those has been notified of allergic reactions to any research drugs or related excipients ? Women during pregnancy or breast feeding ? Other malignant tumors. ? Subjects with other diseases or states that would affect the results of the study or increase the occurrence of treatment-related adverse reactions based on the researchers consideration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactLI Xiao
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed