NCT05721300RecruitingNot Applicable
Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer
Zhongshan Hospital (Xiamen), Fudan University1 site in 1 country2,215 target enrollmentStarted: February 10, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,215
- Locations
- 1
- Primary Endpoint
- Incidence of early liver cancer
Study Overview
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:
- Clinical effect analysis of nucleoside analogs (NAs) group a group and NAs plus interferon group after 48 weeks of treatment;
- Repetitive effect and time effect of different drug treatment at different follow-up time points;
- To evaluate the difference of therapeutic effect of NAs or NAs combined with interferon;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(if one of them is met, it will be excluded)
- •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.
- •In the first 6 months of screening, they received NA (such as lamivudine, adefovir dipivoxil tablets) or interferon treatment with high drug resistance rate;
- •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.
- •The laboratory examination showed liver failure during screening.
- •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.
- •It is accompanied by hepatitis C virus（HCV）, hepatitis D virus （HDV） and HIV infection.
- •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;
- •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.
- •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.
- •Have a history of allergy to nucleoside analogues.
- •The researchers believed that the compliance of the subjects was poor.
- •The researcher believes that the subject is not suitable to participate in this study.
Arms & Interventions
experience group
Experimental
patients receive NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combine with interferon treatments for 48weeks, and then continue NAs treatment
Intervention: NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combined with interferon treatments (Drug)
control group
Active Comparator
patients receive NAs treatment（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"）
Intervention: NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） treatments (Drug)
Outcomes
Primary Outcomes
Incidence of early liver cancer
Time Frame: 1-3 years
To compare the incidence of early liver cancer in different treatment groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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