Adebrelimab + Apatinib in Advanced HCC Post-Systemic Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSong Peng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily participate in this study and sign the informed consent form;
Aged ≥ 18 years (calculated as of the date of signing the informed consent form), male or female;
Pathologically or clinically confirmed hepatocellular carcinoma (HCC);
Have previously received at least one or more lines of systemic therapy (targeted therapy with or without immunotherapy);
Disqualifiers
Previously received PD-L1 immunotherapy or apatinib targeted therapy;
No clear tumor-feeding artery identifiable by angiography;
Known cholangiocellular carcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; having other active malignant tumors (except HCC) within 5 years or concurrently. Locally cured tumors such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment;
Allergic to the investigational drugs;
Trial design
Design model
Single group
Treatments tested in this trial
Adebrelimab + Apatinib
DrugAdebrelimab: 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.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: Adebrelimab + Apatinib Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Song Peng
Lead sponsor
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Sponsor institution
Source ClinicalTrials.gov
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