Patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who progressed after prior systemic therapy (targeted ± immunotherapy) are enrolled. Primary endpoint: objective response rate (ORR). Planned enrollment: 47 subjects. Eligible patients receive adebrelimab + apatinib. After informed consent and screening, treatment starts: Adebrelimab 1200mg IV on D1, Q3W; apatinib 250mg oral QD, continuous. 21-day cycle. Treatment continues until intolerable toxicity, consent withdrawal, RECIST v1.1-proven progression (may continue if clinically beneficial), or protocol-specified criteria (whichever first). Safety follow-up on D1 of each cycle; imaging every 2 cycles (6-8 weeks) for efficacy. Post-treatment: continued safety and survival follow-up.
In this study, patients with locally advanced unresectable or metastatic hepatocellular carcinoma who have previously received systemic therapy (targeted therapy with or without immunotherapy) and developed drug resistance and progression will be selected as the research subjects. The study takes the objective response rate (ORR) as the primary endpoint. It is planned to enroll 47 subjects. Eligible patients will receive adebrelimab in combination with apatinib for treatment. After subjects are fully informed, sign the informed consent form, and pass the screening, they will receive the study treatment. Adebrelimab will be administered at a fixed dose of 1200 mg by intravenous infusion on D1, once every 21 days (Q3W). It will be combined with apatinib at a dose of 250 mg (0.25 g), taken orally once a day (QD), and continuously administered. A 3 - week (21 - day) period will be considered one treatment cycle. The study treatment will continue until the subject experiences intolerable toxic reactions, withdraws informed consent, disease progression confirmed by the investigator according to RECIST v1.1 (when a subject has disease progression as defined by RECIST v1.1, if the investigator assesses that the subject still has clinical benefits and can tolerate the study treatment, the subject may continue to receive the study drug; if it is considered that the subject no longer has clinical benefits, the treatment may be terminated), or other treatment termination criteria specified in the protocol, whichever occurs first. After subjects are enrolled in the study, safety follow - up visits will be conducted on D1 of each treatment cycle. Imaging examinations will be performed once every 2 treatment cycles (6 - 8 weeks) to evaluate the efficacy. After the end of treatment, safety follow - up visits and survival follow - up will continue.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Adebrelimab: A fixed dose of 1200 mg is administered as an intravenous infusion over 30 minutes (not less than 20 minutes and not more than 60 minutes, including the flushing phase), once every 3 weeks (Q3W). The interval between two administrations should not be less than 12 days. The maximum treatment duration is 6 courses. Apatinib: 250 mg, once daily (QD), taken orally within half an hour after a meal, continuously, with a 3 - week (21 - day) cycle. The maximum treatment duration is 6 courses.
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Shenzhen, Guangdong, China
Objective Response Rate (ORR)
Objective Response Rate (ORR): It refers to the percentage of subjects who achieve complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1, mRECIST, or imRECIST (for CR and PR under the imRECIST criteria, they can occur after radiographic disease progression).
Time frame: up to one year
Median Progression-free survival
It refers to the time from the first occurrence of radiological disease progression or death (whichever comes first), as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST. For radiological disease progression identified under the imRECIST criteria, if it is evaluated as response or stable disease after ≥4 weeks, this progression will not be considered a PFS event.
Time frame: up to one year
Time to Progression (TTP)
It refers to the time from the date of starting treatment to the occurrence of radiological disease progression, as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST. For radiological disease progression identified under the imRECIST criteria, if it is evaluated as response or stable disease after ≥4 weeks, this progression will not be considered a TTP event.
Time frame: up to one year
Disease Control Rate (DCR)
It refers to the percentage of subjects who achieve complete response (CR), partial response (PR), or stable disease (SD) lasting for ≥8 weeks, as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST (CR, PR, and SD under the imRECIST criteria can occur after radiographic disease progression).
Time frame: up to one year
Duration of Response (DOR)
It refers to the time from the first documentation of objective response (CR or PR) to the first occurrence of radiographic disease progression or death (whichever comes first), as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST. For radiographic disease progression under the imRECIST criteria, if it is assessed as response or stable disease after ≥4 weeks, it will not be regarded as a progression event for DoR calculation.
Time frame: up to one year
Overall Survival (OS)
It refers to the time from randomization (or enrollment) to death from any cause.
Time frame: up to one year
Adverse Event (AE)
Adverse Event (AE) refers to all adverse medical events that occur in subjects after they receive the investigational product, which can present as symptoms, signs, diseases, or abnormal laboratory test results, but are not necessarily causally related to the investigational product. The collection of AE information starts from the time when the subject signs the informed consent form and continues until the end of the safety follow-up period (30 days after the last dose) or until the initiation of a new anti-tumor drug.
Time frame: up to one year
Serious Adverse Event (SAE)
Serious Adverse Event (SAE) refers to medical events occurring in subjects after receiving any dose of the investigational product, including those requiring hospitalization or prolongation of existing hospitalization, causing disability, impairing work capacity, endangering life, resulting in death, or leading to congenital malformations.
Time frame: up to one year
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