Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer

Not Applicable

Recruiting

• Conditions: Chronic Hepatitis B; Hepatocellular Carcinoma
• Interventions: Drug: NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） treatments; Drug: NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combined with interferon treatments

• Registration Number: NCT05721300
• Lead Sponsor: Zhongshan Hospital (Xiamen), Fudan University

Brief Summary

The goal of this clinical trial is to test the outcomes of HBsAg(+) patients in the treatments of NAs vs NAs plus IFN . The main questions it aims to answer are:

1. Clinical effect analysis of nucleoside analogs (NAs) group a group and NAs plus interferon group after 48 weeks of treatment;

2. Repetitive effect and time effect of different drug treatment at different follow-up time points;

3. To evaluate the difference of therapeutic effect of NAs or NAs combined with interferon;

4. Follow up and compare the incidence of early liver cancer in each group. Participants will be asked to receive NAs or NAs combined with interferon treatments, and Regular blood sampling and color ultrasound examination.

Researchers will compare control group to see if occurrence of liver cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study Start: 2023-02-10
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2215

Inclusion Criteria

Not provided

Exclusion Criteria

(if one of them is met, it will be excluded)

1. Previous history of decompensated liver function or clinical symptoms of decompensated liver disease at baseline, such as hepatic encephalopathy, esophageal variceal bleeding, ascites, splenomegaly, etc.
2. In the first 6 months of screening, they received NA (such as lamivudine, adefovir dipivoxil tablets) or interferon treatment with high drug resistance rate;
3. Have received immunosuppressive agents or other immunomodulators (such as thymosin), systemic cytotoxic drugs, and effective antiviral therapy including Chinese herbal medicine (such as ganciclovir, lobcavir, and valaciclovir) within 6 months before screening.
4. The laboratory examination showed liver failure during screening.
5. There are evidences supporting the diagnosis of hepatocellular carcinoma, such as suspicious lesions found by ultrasound or imaging and/or serum alpha-fetoprotein (AFP)>50ug/L.
6. It is accompanied by hepatitis C virus（HCV）, hepatitis D virus （HDV） and HIV infection.
7. Presence of other liver diseases: combined with other pathogen infection, drug-induced liver injury, alcoholic hepatitis, nonalcoholic steatohepatitis, autoimmune liver disease, systemic diseases involving the liver, etc;
8. Subjects have other serious or active psychosomatic diseases, which may affect patients' treatment, evaluation or compliance with the study protocol. It includes any uncontrolled kidney, heart, lung, vascular, neurological, digestive, metabolic diseases (diabetes, thyroid and adrenal diseases), immune deficiency diseases or tumors with clinical significance.
9. There are contraindications to interferon treatment. Absolute contraindications include pregnancy, psychiatric history, uncontrolled epilepsy, decompensated cirrhosis, uncontrolled autoimmune disease, severe infection, retinal disease, heart failure, chronic obstructive pulmonary disease and other basic diseases. Relative contraindications include thyroid disease, past depression, uncontrolled diabetes, hypertension, and heart disease.
10. Have a history of allergy to nucleoside analogues.
11. The researchers believed that the compliance of the subjects was poor.
12. The researcher believes that the subject is not suitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） treatments	patients receive NAs treatment（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"）
experience group	NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combined with interferon treatments	patients receive NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combine with interferon treatments for 48weeks, and then continue NAs treatment

Primary Outcome Measures

Name	Time	Method
Incidence of early liver cancer	1-3 years	To compare the incidence of early liver cancer in different treatment groups

Trial Locations

Locations (1)

Boheng Zhang; 🇨🇳 Xiamen, Fujian, China