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

Primary Purpose

Hepatocellular Carcinoma, Chronic Hepatitis B

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NAs("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") combined with interferon treatments
NAs ("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") treatments
Sponsored by
Zhongshan Hospital (Xiamen), Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Chronic hepatitis B (CHB), hepatocellular carcinoma (HCC), nucleos(t)ide analogues (NAs), interferon

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (if one of them is met, it will be included): 1. HBsAg positive patients without liver cirrhosis: Chronic hepatitis B virus(HBV) infected persons with positive serum HBV-DNA, if their alanine aminotransferase(ALT) continues to be abnormal and other causes of ALT increase are excluded; In patients with positive serum HBV-DNA and normal ALT, liver histology showed obvious liver inflammation (≥ G2) or fibrosis (≥S2); ALT continues to be normal (once every 3 months, lasting for 12 months), but there is a family history of cirrhosis/liver cancer and the age is>30 years old; ALT is continuously normal (once every 3 months, lasting for 12 months), there is no family history of liver cirrhosis/liver cancer but the age is more than 30 years old, fibroscan or liver histology shows obvious liver inflammation or fibrosis; Chronic HBV infected persons with negative serum HBV DNA who are receiving NA treatment or who have previously received NA treatment. 2. HBsAg positive with iver cirrhosis patients Patients with compensatory cirrhosis, regardless of ALT or HBeAg status. The diagnosis of hepatitis B cirrhosis is in accordance with the diagnostic criteria of Chronic Hepatitis B (2019). It shall conform to the following (1) and (2) (pathological diagnosis), or (1) and (3) (clinical diagnosis). At present, HBsAg is positive, or HBsAg is negative, HBcAb is positive, and there is a clear history of chronic HBV infection (HBsAg positive in the past>6 months), excluding other causes. Pathology of liver biopsy was consistent with liver cirrhosis. two or more of the following 5 items are met, and non cirrhotic portal hypertension is excluded: ① Imaging examination shows signs of cirrhosis and (or) portal hypertension; ② Endoscopy showed esophageal and gastric varices; ③ The determination of liver hardness is consistent with liver cirrhosis; ④ Blood biochemical examination showed that the albumin level decreased (<35g/L) and/or prothrombin time(PT) prolonged (>3s longer than the control); ⑤ Blood routine examination showed that platelet count was<100 * 10 ^ 9/L. 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.

Sites / Locations

  • Boheng ZhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experience group

control group

Arm Description

patients receive NAs("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") combine with interferon treatments for 48weeks, and then continue NAs treatment

patients receive NAs treatment("Entecavir"or"Tenofovir"or"Tenofovir alafenamide")

Outcomes

Primary Outcome Measures

Incidence of early liver cancer
To compare the incidence of early liver cancer in different treatment groups

Secondary Outcome Measures

Full Information

First Posted
December 22, 2022
Last Updated
February 7, 2023
Sponsor
Zhongshan Hospital (Xiamen), Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05721300
Brief Title
Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer
Official Title
Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Hospital (Xiamen), Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Chronic Hepatitis B
Keywords
Chronic hepatitis B (CHB), hepatocellular carcinoma (HCC), nucleos(t)ide analogues (NAs), interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2215 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experience group
Arm Type
Experimental
Arm Description
patients receive NAs("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") combine with interferon treatments for 48weeks, and then continue NAs treatment
Arm Title
control group
Arm Type
Active Comparator
Arm Description
patients receive NAs treatment("Entecavir"or"Tenofovir"or"Tenofovir alafenamide")
Intervention Type
Drug
Intervention Name(s)
NAs("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") combined with interferon treatments
Other Intervention Name(s)
IFN group
Intervention Description
NAs("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") combine with interferon treatments for 48 weeks, and then continue with NAs treatment("Entecavir"or"Tenofovir"or"Tenofovir alafenamide")
Intervention Type
Drug
Intervention Name(s)
NAs ("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") treatments
Intervention Description
patients receive NAs("Entecavir"or"Tenofovir"or"Tenofovir alafenamide") treatment at least 48 weeks
Primary Outcome Measure Information:
Title
Incidence of early liver cancer
Description
To compare the incidence of early liver cancer in different treatment groups
Time Frame
1-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (if one of them is met, it will be included): 1. HBsAg positive patients without liver cirrhosis: Chronic hepatitis B virus(HBV) infected persons with positive serum HBV-DNA, if their alanine aminotransferase(ALT) continues to be abnormal and other causes of ALT increase are excluded; In patients with positive serum HBV-DNA and normal ALT, liver histology showed obvious liver inflammation (≥ G2) or fibrosis (≥S2); ALT continues to be normal (once every 3 months, lasting for 12 months), but there is a family history of cirrhosis/liver cancer and the age is>30 years old; ALT is continuously normal (once every 3 months, lasting for 12 months), there is no family history of liver cirrhosis/liver cancer but the age is more than 30 years old, fibroscan or liver histology shows obvious liver inflammation or fibrosis; Chronic HBV infected persons with negative serum HBV DNA who are receiving NA treatment or who have previously received NA treatment. 2. HBsAg positive with iver cirrhosis patients Patients with compensatory cirrhosis, regardless of ALT or HBeAg status. The diagnosis of hepatitis B cirrhosis is in accordance with the diagnostic criteria of Chronic Hepatitis B (2019). It shall conform to the following (1) and (2) (pathological diagnosis), or (1) and (3) (clinical diagnosis). At present, HBsAg is positive, or HBsAg is negative, HBcAb is positive, and there is a clear history of chronic HBV infection (HBsAg positive in the past>6 months), excluding other causes. Pathology of liver biopsy was consistent with liver cirrhosis. two or more of the following 5 items are met, and non cirrhotic portal hypertension is excluded: ① Imaging examination shows signs of cirrhosis and (or) portal hypertension; ② Endoscopy showed esophageal and gastric varices; ③ The determination of liver hardness is consistent with liver cirrhosis; ④ Blood biochemical examination showed that the albumin level decreased (<35g/L) and/or prothrombin time(PT) prolonged (>3s longer than the control); ⑤ Blood routine examination showed that platelet count was<100 * 10 ^ 9/L. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yanfang wu
Phone
15980017053
Email
wu.yanfang@zsxmhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
boheng zhang
Organizational Affiliation
Zhongshan Hospital (Xiamen), Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Boheng Zhang
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yanfang wu, master
Phone
15980017053
Email
wu.yanfang@zsxmhospital.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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