hepatocellular carcinoma
Conditions
Interventions
experimental group:Oxaliplatin 85mg/m2 d1+ leucovorin 400mg/m2 d1+ fluorouracil 400mg/m2 rapid intravenous infusion, 2400mg/m2 continuous intravenous infusion for 46 hours, q3w+ bevacizumab 7.5mg/kg d
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects with a clinical or pathological diagnosis of hepatocellular carcinoma (HCC) confirmed by radiographic evidence of metastases beyond the liver were included. The clinical diagnostic criteria for HCC were based on the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition). 2) Inclusion criteria consisted of individuals aged between 18 and 75 years, regardless of gender. 3) Participants with a predicted survival time of at least 12 weeks were eligible for enrollment. 4) Eastern Cooperative Oncology Group performance status (ECOG) score ranging from 0 to 1 was required. 5) Eligible patients had experienced disease progression outside the liver following prior immunotherapy treatment with standard targeted agents such as small molecule tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib, donafinib, apatinib, regorafenib, bevacizumab), as well as PD-L1/PD-1 monoclonal antibodies (e.g., pembrolizumab, sintilizumab, carrelizumab, tilelizumab). Additionally, intrahepatic lesions should have been relatively stable or absent. 6) According to RECIST1.1 criteria, at least one measurable tumor lesion outside the liver with a maximum diameter =1cm needed to be identified through spiral CT imaging conducted within 28 days before enrollment. 7) Prior to study drug administration and within one week before enrollment: hemoglobin level should be =90g/L; platelet count =70×10^9/L; white blood cell count =3.0×10^9/L; neutrophil count =1.5×10^9/L; total bilirubin =1.5 times upper limit of normal (=3 times if there are liver lesions); serum creatinine =1.5 times upper limit of normal; alanine aminotransferase and aspartate aminotransferase levels =2.5 times upper limit of normal (=5 times if there are liver lesions). 8) Patients' liver function assessed using Child-Pugh score should not exceed 7 points. 9) Written informed consent was obtained from all participants who voluntarily agreed to participate in this study.
Exclusion criteria
Exclusion criteria: 1) A history of other malignancies with disease-free survival less than 5 years (excluding cured basal cell carcinoma of the skin, cured carcinoma in situ of the cervix, and gastrointestinal cancer proven cured by endoscopic mucosal resection). 2) Severe esophagogastric varices or major gastrointestinal bleeding within the past 3 months. 3) Immunodeficiency disease or HIV infection. 4) Severe acute uncontrolled infection (infection causing fever above 38 °C). 5) History of active hepatitis B or active hepatitis C, with a hepatitis B virus (HBV) DNA titer test result equal to or greater than 2000 IU/mL (or 1×10^4 copies/mL), and a hepatitis C virus (HCV) RNA test result equal to or greater than the detection limit. 6) Severe liver and kidney dysfunction; recent history of myocardial infarction within the past 3 months. 7) Subjects with an active or previous autoimmune disease or risk of relapse. However, subjects with type 1 diabetes, hypothyroidism requiring hormone-replacement therapy only, or skin conditions requiring no systemic treatment such as vitiligo, psoriasis, or alopecia were allowed. 8) History of interstitial lung disease or noninfectious pneumonia that may hinder evaluation or management of study-drug-related pulmonary toxicity due to symptomatic disease or previous pulmonary history. 9) Subjects with a history of active pulmonary tuberculosis infection within one year before the first dose of study drug were eligible for enrollment if they had a history more than one year prior without evidence of current active pulmonary tuberculosis as determined by the investigator. 10) Patients with chronic diarrhea lasting for an extended period or complete intestinal obstruction. 11) Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of the study drug. Note: In absence of active autoimmune disease. 12) complicated with other serious medical or surgical diseases that affect organ function, and the investigator considers that they are not suitable for participating in the trial; 13) participated in other clinical trials of new drugs within 4 weeks; 14) pregnant or lactating women or patients of childbearing potential (men or women with menopause less than 1 year) who are unwilling to use contraception; 15) subjects with a history of allergic or hypersensitive reactions to a study drug component; 16) who were deemed by the investigator to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of intrahepatic lesions;Objective response rate of extrahepatic lesions;Overall objective response rate;Overall survival time;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactYu Yang
West China Hospital, Sichuan University
Outcome results
None listed