advanced unresectable hepatocellular carcinoma
Conditions
Interventions
Intervention group:Adebrelimab
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age = 18 years, with no restriction on sex; 2.Histologically or clinically confirmed diagnosis of hepatocellular carcinoma (HCC); 3.Availability of representative tumor tissue suitable for central laboratory assessment of PD-L1 and/or other biomarker status; 4.Unresectable advanced hepatocellular carcinoma at BCLC stage B or C (patients with PVTT-Vp4 are excluded); 5.No prior systemic therapy for hepatocellular carcinoma; or disease progression or residual lesions after prior local treatment for hepatocellular carcinoma (including but not limited to surgery, ablation, radiotherapy, or transarterial chemoembolization [TACE]), with an interval of at least 1 month between the last local treatment and enrollment; 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 7.Child–Pugh class A or class B (score of 7); 8.No history of autoimmune disease; 9.Estimated life expectancy of at least 3 months; 10.At least one measurable lesion according to RECIST version 1.1 (longest diameter >=10 mm on spiral CT for non-nodal lesions or short-axis diameter >=15 mm for lymph nodes; lesions previously treated with local therapy may be considered target lesions only if definite progression is documented according to RECIST v1.1); 11.Adequate hematologic, hepatic, and renal function; 12.Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the end of the study; men must agree to use effective contraception during the study and for 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1.Known cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma, or fibrolamellar carcinoma; presence of any other active malignancy within the past 5 years or concurrently, except for definitively treated localized tumors, such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ; 2.Severe allergy to iodinated contrast agents that precludes hepatic arterial infusion chemotherapy (HAIC); 3.Use of immunosuppressive agents or systemic corticosteroids for the purpose of immunosuppression within 1 month prior to enrollment; 4.Active infection that cannot be adequately controlled; 5.Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices with bleeding or a high risk of bleeding; 6.Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapeutic intervention; 7.Pregnancy, suspected pregnancy, or breastfeeding; 8.Current use or recent use (within 10 days prior to initiation of study treatment) of aspirin at a dose >325 mg/day (maximum antiplatelet dose), or dipyridamole, ticlopidine, clopidogrel, or cilostazol; 9.History of thrombotic or embolic events within 6 months prior to initiation of study treatment, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage, or cerebral infarction) and pulmonary embolism; 10.Congenital or acquired immunodeficiency; 11.Any of the following conditions within 12 months prior to study initiation: myocardial infarction, severe or unstable angina, or congestive heart failure; 12.Renal insufficiency requiring dialysis; 13.History of organ transplantation; 14.Any other severe acute or chronic medical or psychiatric condition, or clinically significant laboratory abnormality that, in the investigator’s judgment, may increase the risk associated with study participation, interfere with interpretation of the study results, or render the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of relief;Progression-free survival; | — |
Countries
China
Contacts
Public ContactJiang Xiaofeng
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed