* Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). The primary efficacy endpoints are HBsAg seroconversion rate (HBsAg disappearance and HBsAb appearance), and HCC recurrence rate at week 49. Secondary Objective: To evaluate the safety of the HBV sandwich combination therapy through various safety indicators. Safety Indicators as follows: 1) Vital Signs: Monitoring systolic and diastolic blood pressure, pulse, respiration, and body temperature; 2) Physical Examination: Comprehensive physical assessments during the study; 3) 12-lead Electrocardiogram: Conducted to monitor cardiac health; 4) Clinical Laboratory Tests: Including blood routine, urine routine, blood biochemistry (focusing on liver and kidney function), coagulation function; 5) Injection Site Reactions: Monitoring for any local adverse effects from injections; 6) Adverse Events (AEs) and Serious Adverse Events (SAEs): Documentation of any AEs or SAEs occurring during treatment. * Study Design: This study comprises three distinct stages:
1. Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations. 2. Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU/mL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU/mL post HT-102, participants will enter the follow-up period directly. 3. Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters. * End of Study:
The study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.
\- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.
Male or female subjects aged ≥18 weeks and ≤70 years, with an expected survival time of more than 12 months;
HCC subjects who have undergone radical surgery or ablation therapy, and no residual tumor lesions in the liver (R0 resection) were found in the postoperative review, and the postoperative pathological specimens confirmed that they were primary liver cancer and had evidence of chronic hepatitis, no evidence of extrahepatic metastasis, and did not require postoperative adjuvant therapy for low- and medium-risk subjects;
Barcelona Clinic Liver Cancer (BCLC) stage 0 or A; Child-Pugh liver function grade A during the screening period, ECOG score 0;
No imaging evidence of invasion of the main portal vein branches; Clinically diagnosed with chronic hepatitis B (serum HBsAg positive ≥6 months);
Liver transplant or liver transplant candidate; previous or current diagnosis of psychiatric illness or major depression;
Other malignancies, except for carcinoma in situ of the cervix and/or non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [breast cancer in situ], and T1 [tumor invading the lamina propria]). Any cancer that has been effectively treated for more than 3 years before participating in the study is allowed;
Those with clinical symptoms of brain metastases, or other evidence that the subjects' brain metastases have not been controlled, and/or meningeal metastases, are judged by the researchers to be unsuitable for inclusion;
Past or current ascites, esophageal or gastric varicose bleeding caused by portal hypertension, hepatorenal syndrome, hepatic encephalopathy or liver failure, suspected cirrhosis or compensated cirrhosis, etc.;
Single group
NA(s)+HT-102+FD-001
DrugNucleos(t)ide analogues will be administrated throughout the entire treatment course; Patients will be injected with HT-102 once in Day1 (Week1), Day8 (Week2), Day15 (Week3), Day22 (Week4); Patients will be injected with FD-001 once in Day29 (Week5), Day57 (Week9), Day85 (Week13), Day113 (Week17), Day141 (Week21), Day169 (Week25) after confirmed reduction of serum HBsAg to below 10 IU/mL.
Positive convention rate of HBsAb
evaluate the seroconversion rate of HBsAg (defined as the loss of HBsAg with the concurrent appearance of anti-HBs antibodies).
Proportion of subjects with ≥ 0.5 log or ≥1 log reduction in serum HBsAg levels from baseline
to evaluate the efficacy of NA(s)+HT-102+FD-001
HBsAg changes
to evaluate the efficacy of NA(s)+HT-102+FD-001
HBsAg clearance rate
HBsAg clearance rate defined as undetectable HBsAg or HBsAg below 10 IU/mL
HBsAg seroconversion rate
HBsAg seroconversion rate defined as loss of HBsAg with concurrent development of HBsAb
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